Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Symptoms and General Pathology

Prostatic Neoplasms

Erectile Dysfunction

Urinary Incontinence

Enuresis

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Urination Disorders

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Lower Urinary Tract Symptoms

Urological Manifestations

Mental Disorders

Psychotic Disorders

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Patients with localized prostate cancer underwent transperitoneal robot-assisted laparoscopic radical prostatectomy

Robot-assisted laparoscopic radical prostatectomy

Brasil S Neto, PhD

Eduardo T Cachoeira, MD

Robot-assisted laparoscopic radical prostatectomy (RALRP) is a surgical technique for the treatment of prostate cancer. The aim of this study was to report our initial experience with RALRP, by applying the concept of pentafecta. Pentafecta consists of the five main outcomes in the postoperative period of RALRP: erectile dysfunction, urinary incontinence, postoperative complications, surgical margins and biochemical failure.

This study will describe a initial experience in RALRP in Brazilian University Hospital. The follow-up of patients was performed as an examination at the medical consultation every three months. Complications were categorized according to the Clavien classification system. Biochemical failure was established by PSA level. Continence was defined as patients who remain dry and who do not require any kind of protection in their everyday activities. Sexual potency was defined as the ability to get and keep an erection for long enough to have satisfying sexual relations with or without the use of type-5 phosphodiesterase inhibitors (PDE-5) and a Sexual Health Inventory for Men (SHIM) score greater or equal to 21. Positive surgical margin is defined as the presence of neoplastic glands in direct contact with the ink on the surface of the piece, with no interposed connective tissue.

Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy

Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy: First 120 Cases in Brazilian University Hospital

Sexual Health Inventory for Men (SHIM) score greater or equal to 21.

Continence was defined as patients who remain dry and who do not require any kind of protection.Patients will be questioned in the postoperative consultations if there is a need to use some protection.

Complications were categorized according to the Clavien classification system.

Biochemical failure was established by PSA level grater or equal to 0,2 ng/ml.

It is defined as the presence of neoplastic glands in direct contact with the ink on the surface of the piece.

Hospital de Clinicas de Porto Alegre

Mouth and Tooth Diseases

Rare Diseases

Recurrence

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

All subjects in this study will receive surgery to treat their oral lesions. The margins (or boundaries) of the tissue to be removed during surgery will be defined by 2 different procedures (or study arms) in the operating room.

The Control arm. Surgical boundaries for oral lesions will be defined under regular white light.

All subjects in this study will receive surgery to treat their oral lesions. The margins (or boundaries) of the tissue to be removed during surgery will be defined by 2 different procedures (or study arms) in the operating room.

The FV arm (experimental arm). Surgical boundaries for oral lesions will be defined by FV.

The trial will randomize 200 patients - 100 in the control arm (using conventional white light approach).

Fluorescence visualization device

The trial will randomize 200 patients - 100 in the FV arm (using FV guided the surgery margin)

Helen Chiu

Sylvia Lam

Joseph Dort, Dr.

Paul Kerr, Dr.

Rob Hart, Dr.

John Yoo, Dr.

Mike Odell, Dr.

Kevin Higgins, Dr.

Karen Kost, Dr.

Catherine Poh, DDS, PhD

Scott Durham, Dr.

Miriam Rosen, Ph.D

Calum MacAulay, Ph.D

Penelope Brasher, Ph.D

Stuart Peacock, Ph.D

Kitty Corbett, Ph.D

Kenneth Berean, Dr.

Donald Anderson, Dr.

Michele Williams, DDS

Robert Hart, Dr.

Oral squamous cell carcinoma (SCC) is a global disease responsible for \~300,000 new cancer cases each year. Local recurrence (\~30% of cases) and formation of second primary malignancy are common.2, 3 Cosmetic and/or functional compromise associated with treatment of disease stage is often significant. These statistics underscore the urgent need to develop a better approach in order to control this deadly disease.

It is becoming increasingly apparent that oral cancers develop within wide fields of diseased tissue characterized by genetically altered cells that are widespread across the oral cavity and present in clinically and histologically normal oral mucosa. Complete removal of these lesions is difficult because high-risk changes frequently go beyond clinically visible tumor. In recognition of this, current 'best practice' is to remove SCC with a significant width (usually 10 mm) of surrounding normal-looking oral mucosa. However, since occult disease varies in size such approach often results in over-cutting (causing severe cosmetic and functional morbidity) or under removal of disease tissue, as evidenced by frequent positive surgical margins and high local and regional recurrence - a failure of the 'best practice.

There is a wealth of literature that supports the use of tissue autofluorescence in the screening and diagnosis of precancers in the lung, uterine cervix, skin and oral cavity. This approach is already in clinical use in the lung and the mechanism of action of tissue autofluorescence has been well described in the cervix. Changes in fluorescence reflect a complex interplay of alterations to fluorophores in the tissue and structural changes in tissue morphology, each associated with progression of the disease.

As one of the internationally leading teams in applying tissue fluorescence technology, we have shown that direct fluorescence visualization (FV) tools can identify clinically visible or occult premalignant and malignant lesions that are associated with lesions at risk, with high-grade histology and high-risk molecular change. In a recently small scaled, retrospective study, we have shown that FV helped surgeons in the operating room to determine the extent of the high-risk FV field surrounding the cancer and resulted in remarkably lower 2-year recurrence rates (0% for FV-guided vs. 25% for those without FV-guided approach). There is need to design a larger scale prospective, randomized controlled (Phase III) trial to gather strong evidence in proving the efficacy of the surgery approach using this adjunct tool.

To establish the evidence supporting the change in clinical practice using FV-guided surgery. There are 3 objectives.

2.1. Objective 1 (Clinical evidence): To assess the effect of FV-guided surgery on the recurrence-free survival of histologically confirmed disease within the context of a randomized controlled trial (efficacy). Hypothesis: FV-guided surgery will increase the recurrence-free survival.

2.2. Objective 2 (Quality of Life evidence): To establish the cost per recurrence prevented for this approach and assess quality of life issues. Hypothesis: FV-guided surgery can be delivered in a cost effective manner and improve the quality of life of patients 2.3 Objective 3 (Scientific/Molecular evidence): To assess the presence of previously validated molecular markers (microsatellite analysis, LOH) and histological change (quantitative pathology) in surgical margins in a nested case-control study involving a tumor bank created within this project. Hypothesis: FV-guided surgery will spare normal tissue at the same time improving capture of high-risk tissue.

1.0. OBJECTIVES AND APPROACHES: 1.1. Objective 1 (Clinical evidence): To assess the effect of FV-guided surgery on the recurrence-free survival of histologically confirmed disease within the context of a randomized controlled trial (efficacy).

Hypothesis: FV-guided surgery will increase the recurrence-free survival. Approaches: This Aim requires the establishment of a randomized controlled trial of 200 patients which will compare outcome for patients in 2 arms: one with conventional surgery with margin delineated under white light, and the other using FV guidance for margin delineation. Please see attached Appendix 1 for a step-by-step protocol. This comprises a multidisciplinary team of surgeons, pathologists, project coordinators, and FV Specialists. In addition to the presurgery assessment, all participating patients will have 3-month follow-ups for the first 2 years and 6-month for the rest of the study period. Biopsy will occur when clinically warranted or at 2-year post-surgery.

1.2. Objective 2 (Quality of Life evidence): To establish the cost per recurrence prevented for this approach and assess quality of life issues.

Hypothesis: FV-guided surgery can be delivered in a cost effective manner and improve the quality of life of patients.

Approaches: This aim requires the collection of economic and quality of life (QoL) data to establish the cost per recurrence prevented for FV-guided surgery and to assess quality of life impacts. To asses potential psychosocial consequences of FV-guided surgery we will measure global QoL. We will use the validated EQ-5D and Functional Assessment of Cancer Therapy Head and Neck Module (FACT-H\&N) to determine the participant's QoL at each assessment. The questionnaires will be applied at pre-surgery baseline, and at 6-week, 3-month, and 24-month post-surgery follow-ups.

1.3 Objective 3 (Scientific/Molecular evidence): To assess the presence of previously validated molecular markers (microsatellite analysis, LOH) and histological change (quantitative pathology) in surgical margins in a nested case-control study involving a tumor bank created within this project.

Hypothesis: FV-guided surgery will spare normal tissue at the same time improving capture of high-risk tissue.

Approaches: This Aim requires the retrieval and cutting of the archive material for a nested control study. The estimate number of cases reach outcome is 30 (5% of FV group (100) + 25% of control group (100). Additionally, 60 matched controls will be selected (matched by gender, age, smoking habit, and anatomical site). This Aim is critical to demonstrate a shift in field, sparing normal tissue while catching high-risk occult tissue. Samples for the nested molecular analysis will be performed in Rosin's Lab (for microsatellite analysis) and Cancer Imaging at BC Cancer Agency (Dr. MacAulay for qualitative Pathology). The protocols used to analyze these samples have been published.

2.0. STUDY TOOL - VELSCOPE® We have recently developed a simple hand-held field-of-view device for direct visualization of tissue fluorescence in the oral cavity. This tool is currently commercially available as VELScope® (LED Med Inc., White Rock, BC). We have begun a longitudinal study to explore the effect of FV in defining the surgical margin on outcome of oral cancer surgery27. Between 2004 and 2008, 60 patients with a ≤4 cm oral cancer entered the study. Each case was treated with surgical excision alone and was followed for at least 12 months. Thirty-eight patients had FV-guided surgery, with the surgical margin placed at 10 mm beyond the perimeter of autofluorescence loss. The remaining patients (control group) had the surgical margin placed at 10 mm beyond the tumor edge defined by standard white-light examination. Among those, 7 of the 60 cases (12%) have developed a recurrence of severe dysplasia, carcinoma in situ or squamous cell carcinoma at the treated site, all in the control group (25% versus 0%, P = 0.002). These data suggest the potential utility of autofluorescence changes within this clinical setting. There is a need to design a larger scaled randomized controlled clinical trial to confirm the efficacy of FV-guided surgery.

We are also using FV to monitor the potential re-emergence of regions of autofluorescence loss at treated sites in the cases accrued to the longitudinal study and are currently completing an interim assessment of these monitoring results. Autofluorescence loss persists in some cases, increasing in size and intensity over time and giving rise to a clinical lesion containing dysplasia or cancer.

3.0 Core members of the trial and project management We have a well-built core group with long-term and strong working relationships, including surgeons (Drs. Anderson (Co-PI) and Durham), Pathologists (Drs. Berean (Co-PI) and Zhang), and Oral Medicine (Drs. Poh (PI) and Williams), and are in a world-leading position in using fluorescence visualization in operating room and in follow-up. Dr. J. Lee, collaborator, from M.D. Anderson Cancer Centre and has extensive experience in clinical trials with special expertise in randomized controlled trial. He will be the trialist in this project, design a program for patient randomization, oversee the trial protocol, and work with local statistician (Prof. Chen) for day-to-day data management. Professor Jiahua Chen, Department of Statistics, the University of British Columbia will serve as the biostatistician to the trial and will be responsible for the data analysis and submission of interim analyses to the Data Safety Monitoring Board.

4.0 Basic trial design The proposed study will be a double-blinded, randomized controlled Phase III study to evaluate the effect of FV-guided surgery in patients diagnosed with severe dysplasia, carcinoma in situ and invasive squamous cell carcinoma and undergoing surgery treatment with an intent-to-cure. The trial will randomize 200 patients -100 in the FV arm (using FV guided the surgery margin) and 100 in the control arm (using conventional white light approach). The trial period is 5 years - 2 years to complete accrual and 3 more years of follow-up.

Efficacy of Optically-guided Surgery in the Management of Early-staged Oral Cancer - COOLS TRIAL

Canadian Optically Guided Approach for Oral Lesions Surgical Trial - COOLS

Terry Fox Research Institute

British Columbia Cancer Agency

University of British Columbia

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

High-risk margins were defined as R1 or R2 surgical margins or local recurrence during follow-up.

Low-risk margins were defined as R0 surgical margin meanwhile arising distant metastasis during follow-up.

extracted the tumor and peritumor radiomic feature from the preoperative enhanced chest CT

tumor and peritumor radiomic feature

Guangming Lu

The investigators retrospectively collected the participants with T3 and T4, N0-2, M0 NSCLC patients resected between January 2013 to December 2021 for training and internal validation. The Clinical data, preoperative laboratory results and images were collected. High-risk margins were defined as R1 or R2 surgical margins or local recurrence during follow-up, and the investigators also collected the disease-free survival time. On the Deepwise multi-modal research platform, the images were semi-automatically segmented and expanded outward by 3mm to obtain the peritumor tissue. PyRadiomics was used to extract the radiomic features. LASSO was used to select the features and tumor radiomics model, peritumor model and combined model were built using 5-fold cross-validation. And it was further tested on the independent cohort. Discrimination was assessed by using the C-index and area under the receiver operating characteristic curve (AUC), sensibility, specificity.

A Radiomic Model for Risk of Local Recurrence and DFS for T3 and T4 Non-small Cell Lung Cancer

Development of a Tumor and Peritumor Radiomics-based Model to Predict the High-risk Surgical Margin and Prognosis of T3 and T4 Non-Small Cell Lung Cancer

the time from the surgery time to the recurrence time

Jinling Hospital, China

Director of the Medical Imaging Center of the Jinling Hospital

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

Patients receive standard of care breast surgery and subsequent whole breast irradiation

Breast conserving surgery

Niku KJ Oksala, Professor

The number of breast cancer survivors is constantly growing. Breast conserving surgery (BCS) is equal or superior to mastectomy both regarding survival and quality of life (QoL). Hence, as many patients as possible should be treated using BCS. The results indicate that the rate of mastectomies in Finland is higher than in Europe, while the rate of reoperations due to insufficient margins after BCS is lower in Finland than globally. With this study we aim to identify the optimal balance of radicality and tissue-conservation in BCS.

The aim of this study is to measure the volume of the resected breast tissue and the width of the healthy tissue margins and to compare these with the radiological and histological tumor size and with the size of the breast and their correlation with theoretically optimal and excised volumes.

This is a national prospective multicenter study conducted in five breast units. 250 women with primary, unilateral, cTis-T2 breast cancer eligible for BCS will be recruited. The diagnostics and treatment of the patients will be carried out following the Finnish national guideline. The size of the breast and the radiological size of the tumor will be measured preoperatively using mammograms and MRI. The histological tumor volume and the resection volume will be measured postoperatively. The optimal resection volume is calculated as the difference of the total resection volume and the volume of the tumor with an added 1 cm margin.

To map the impact of the treatment on QoL and body image, the patients are surveyed using EORTC-QLQ-C30 and BREAST-Q Breast Conserving Therapy Module QoL questionnaires preoperatively, 3-8 weeks postoperatively, and two years after the radiotherapy. Objective evaluation of the aesthetic outcome is assessed by the BCCT.core software that uses medical photographs taken at the same time points as the questionnaires are filled.

1. Background

   Breast cancer is the most common cancer worldwide. The prognosis of early-stage breast cancer is good - more than 90 % of the patients are alive five years after diagnosis. Since many patients live decades after the diagnosis, besides oncological outcome, aesthetic, and functional outcomes are important for patients as a factor of quality of life (QoL) and global health. Breast conserving surgery (BCS) is equal or superior to mastectomy (Mx) both regarding survival and quality of life (QoL). Even if a patient has had immediate breast reconstruction their body image is inferior after mastectomy compared to those undergoing BCS.

   The aim of BCS is to remove the tumor with histologically negative margins defined as no ink on tumor for invasive carcinoma and 2 mm histological margin for ductal carcinoma in situ (DCIS). Wider negative margins do not improve local control when BCS is combined with radiotherapy (RT) but predispose patients to larger excision volumes and inferior cosmetic outcomes. Contrastingly, more conservative resections are associated with positive histological margins, which double the risk of tumor recurrence. Therefore, re-operation is performed for positive histological margins. Rates of re-excision vary widely between surgeons and facilities and according to recent international studies are up to 30 %. Re-operation is associated with several adverse outcomes such as delayed adjuvant treatment and impaired cosmetic outcomes and QoL.

   Finding the right balance between BCS and mastectomies, and the optimization of resection volumes are important considerations for surgical care of breast cancer. BCS rate and reoperation rate are both quality indicators of the European Society of Breast Cancer Specialists. The rate of mastectomies for early breast cancer in certified European breast units is approximately 25 %. There is no exact data on the rate of Mxs according to progression for Finland, however, it appears to be higher than in European units. Contrastingly, 8-13 % of the patients having BCS require a reoperation due to positive histological margins in Finland. These findings raise the question whether more BCS could be performed and with smaller macroscopic margins.

   Since the variation in reoperation rates, rates of mastectomies and resection volumes is largely unexplained, more research is needed to identify the root causes to enable effective interventions and raise the standards of care. Tumors and their anatomical location in the breast, breasts of the patients and surgical techniques vary and therefore measuring the BCS is challenging. Additionally, long-term cosmetic and functional outcomes are confounded by the effect of radiotherapy, and final outcome can be observed no earlier than two years after operation. In practice, measuring the ratio of the tumor volume to resection volume could provide comparable data and could even be a quality indicator of BCS. Our team has previously studied the technological innovations for intraoperative margin assessment and conducted retrospective analysis on the breast cancer margins in Finland. To effectively assess the factors affecting the resection volumes and obtained margins, a prospective approach is needed. A multicenter approach gives a comprehensive look on variation between institutions and surgeons. A study of this nature has not been conducted before.
2. Aim of the study

   The aim of this study is to measure the volume of the resected breast tissue and the width of the healthy tissue margins and to compare these with the radiological and histological tumor size and with the size of the breast and their correlation with theoretically optimal and excised volumes. These results help breast surgeons to find optimal balance of radicality and tissue-conservation.

   Primary endpoints
   * What is the effect of breast-related QoL and objective aesthetic outcome, as measured with BCCT.core, of the treatment on patient's overall QoL?
   * Are there differences in resection volumes and patient-related outcomes between surgeons or breast centers?
   * The ratio of theoretically optimal and excised resection volume for the tumor

   Secondary endpoints
   * What is the effect of radiotherapy on breast volume and shape?
   * What is the effect of the preoperative multidisciplinary team (MDT) treatment plan on the results?
   * What is the reoperation rate due to positive histological margins?
   * What is the effect of the tumor subtype, tumor size, DCIS component, tumor palpability or preoperative MRI imaging on the resection margins?
3. Research methods and execution

   3.1 Trial design and participants

   This is a national prospective multicenter study with a sample of 250 patients. The inclusion criterion is primary, unilateral cTis-T2 breast cancer eligible for BCS. Both conventional and volume-displacement oncoplastic techniques can be applied as long as the procedure is unilateral. The patients will be recruited from five Finnish breast units. For one surgeon at least 20 procedures are required. The sample size is powered to detect differences between centres and individual surgeons (alfa=0.05, beta=0.2, effect size 0.3) with the presumed loss of a maximum of 20% of patients at 2-year follow-up in terms of primary endpoints.

   Exclusion criteria for the study are metastatic, bilateral, and hereditary breast cancers or earlier breast cancer of the same or contralateral breast. Also, a symmetrisation procedure of the healthy breast simultaneously with the cancer operation or earlier breast procedures (excluding bilateral reduction mammoplasty/mastopexy) are contraindications. If the patient is not eligible for radiotherapy, has received neoadjuvant treatment, is pregnant or breastfeeding or is unable to provide an informed consent, she is not included in the study.

   For all patients the following data will be collected: age, BMI, comorbidity, smoking status, hormonal status, radiological data of the patient's breasts and the tumor, preoperative MDT data, histopathological data on the tumor and the margins, details of the operative treatment, postoperative complications, and details of the oncologic treatments.

   For all breast units the following characteristics will be collected: annual number of new primary breast cancers and primary breast cancer operations, Mx-rate, number of immediate and delayed breast reconstructions, number of surgeons, information about MDT principles For all breast surgeons the following characteristics will be collected: age, gender, specialty, years of work experience and workplace The diagnostics and treatment of the patients will be carried out following the Finnish national guideline, which is in line with international guidelines. The patients will not undergo any additional laboratory tests or imaging. The data will be collected from examinations done routinely during the diagnostic phase and follow-up phase.

   3.2 Volumetric measurements and the resection ratio

   The breast volume is calculated preoperatively and after radiotherapy by using mammography measurements (breast height, breast width and compression thickness) and the preoperative tumor volume by mammography and/or by the MRI. The effect of radiotherapy on breast size is calculated by comparing the preoperative and postoperative volume of the breast while considering the resection volume.

   The fresh surgical specimen is submerged in saline and its volume is measured using calculations based on Archimedes principle and Newton's third law. The radiological and histological tumor volume is calculated assuming the tumor to resemble an obloid spheroid.

   Optimal resection volume (ORV) is defined as the spherical volume of the tumor with an added 1.0 cm margin of healthy breast tissue. Total resection volume (TRV) is the measured volume of the fresh surgical specimen. TRV is compared to ORV to determine the excess of breast tissue resection (TRV/ORV=CRR) defined as calculated resection rate (CRR). Optimal CCR is 1.0.

   3.3 Quality of life and aesthetic results

   To map the impact of the treatment on QoL and body image, the patients are photographed and surveyed using QoL questionnaires (EORTC-QLQ-C30 version 3.0 and BREAST-Q Version 2.0 Breast Conserving Therapy Module) preoperatively, 3-8 weeks postoperatively and two years after the radiotherapy. Objective evaluation of the aesthetic outcome is assessed by the 'BCCT.core software' - INESC Porto Breast Research group based on medical photographs. The photographs are taken at same time points as QoL questionnaires are filled.

   The tumor-to-TRV ratios are analyzed between surgeons and centers while controlling for potential confounders at 3-8 weeks after surgery. Additionally, the correlation of the factors with aesthetic and QoL measures is analyzed at 3-8 weeks after surgery and 2 years after RT when the effect of radiation and adjuvant therapies is also fully included.
4. Schedule

The trial inclusion will begin in the spring 2022. Before the inclusion we will do a pilot study of five patients to validate the measuring techniques, the QoL questionnaires and the BCCT.core program.

The results will be analyzed at two time points:

1. 3-8 weeks after the operation
2. two years after the radiotherapy

The final results of the study should be available during 2025. The results will be published in peer-reviewed journals of surgical oncology.

Factors Influencing Breast Cancer Resection Volumes And Their Impact on Treatment Outcome (FIBRATIO)

Factors Influencing Breast Cancer Resection Volumes And Their Impact on Treatment Outcome: a Prospective Multicenter Study (FIBRATIO)

What is the effect of breast-related QoL and objective aesthetic outcome, as measured by two QoL questionnires and with BCCT.core, of the treatment on patient's overall QoL?

Are there differences in resection volumes and patient-related outcomes between surgeons or breast centers?

The ratio of theoretically optimal and excised resection volume for the tumor

What is the effect of radiotherapy on breast volume and shape? Breast volume is measured preoperatively and two years after the radiotherapy. Breast volume based on mammogram data calculated using the formula proposed by Kalbhen et al, Am JRoentgenol. 1999: Volume = (π/4) × Breast height × Breast width × Compression thickness in cranio-caudal mammogram. Breast shape is assessed by BCCT.core.

What is the effect of the preoperative multidisciplinary team (MDT) treatment plan on the results? MDT planning will be assessed as YES or NO scale.

What is the reoperation rate due to positive histological margins?

What is the effect of the tumor subtype, tumor size, DCIS component, tumor palpability or preoperative MRI imaging on the resection margins?

Jyväskylä Central Hospital

Turku University Hospital

Kuopio University Hospital

Tampere University Hospital

Yayi He, PHD,MD

This study aims to explore the application of Surface-enhanced Raman Scatting (SERS) technology in lung cancer surgery and clarify its mechanism through multi-omics mass spectrometry platform, and then further prove the clinical transformation value of this technology.

This study intends to apply the intraoperative navigation system based on Surface-enhanced Raman Scatting (SERS) technology to detect the PH of lung tissue, and to evaluate the benign and malignant resection margins of lung tissue based on this. In order to clarify the discrimination mechanism, a multi-omics mass spectrometry platform is planned to study the internal small molecules and pathway changes. In addition, the patients were followed up for five years to explore the correlation between the prognosis of patients and the PH of lung tissues and lymph nodes, which could prove the clinical transformation value of this technology.

Application of SERS Technology Based Intraoperative Navigation System in Lung Cancer

Application of Surface-enhanced Raman Scatting (SERS) Technology Based Intraoperative Navigation System in Lung Cancer

Time from randomization to death (from any cause).

The time from surgery to recurrence or the end of follow-up was defined.

Shanghai Pulmonary Hospital, Shanghai, China

Principal Investigator

Skin Neoplasms

Carcinoma, Squamous Cell

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Neoplasms, Basal Cell

Dermatoscopy not used in decision of surgical margin

Dermatoscopy is used in decision of surgical margin

Dermatoscopy used in decision of surgical margin before resection of basal cell carcinoma or cutaneous squamous cell carcinoma

Dermatoscopy

Fredrik Landström, MD, PhD

Örebro U Hospital

In this randomizid controlled trial the aim is to use dermatoscopy in deciding the resection margin for patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma. The outcome is radical/non radical resection of the lateral margins in the pathology report.

In basal cell carcinoma and especially cutaneous squamous cell carcinoma the prognosis is very good if the tumour is radically removed in the primary resection. In this study we propose that the use of dermatoscopy in deciding the surgical margins can increase the proportion of radically removed tumours. In this randomized clinical trial the use of dermatoscopy in deciding the surgical margins in patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma is assessed. The outcome measure is radical/non radical resection of the lateral margins. In the control group dematoscopy is not used in deciding the surgical margin. 400 patients with suspected or verified BCC or cSCC will be included, 200 in each group.

Dermatoscopy Guided Resection for Skin Cancer

Dermatoscopy Guided Resection Margins in Basal Cell Carcinoma and Cutaneos Squamous Cell Carcinoma

If the side margins in the pathology report is radical or not

Region Örebro County

Associate professor

Neoplasm Metastasis

Lip Neoplasms

Disease Attributes

Patients treated with a 5mm surgical margin for a T1 SCC of the lip.

Patients treated with a 10mm surgical margin for a T1 SCC of the lip.

K Mosterd, MD, PhD

The purpose of this study is to investigate the risk of recurrence and metastasis in patients treated with different surgical margins (5mm vs 10mm) for a T1 squamous cell carcinoma of the lip.

The incidence of head and neck tumors, including lip carcinomas, in increasing. Exact incidences are lacking because in the Dutch National Cancer Registry (NCR) lip carcinomas are registered both as oral cavity carcinomas and skin carcinomas. In 2021, 136 patients with lip cancer were registered in the Netherlands. 90% of patients with lip cancer have localized disease (stage 1) with a 5-year survival rate of more than 90%.

Lip carcinomas usually involve squamous cell carcinomas (SCC). In most cases, the SCC is located on the sun-exposed lower lip. In approximately 90% of lower lip SCCs, the tumor is smaller than 2cm in diameter. According to the current eight edition of the Tumor Node Metastasis (TNM) classification of the American Joint Committee on Cancer (AJCC) and the ninth edition of the Union for Internation Cancer Control (UICC), it is classified as tumor stage I.

Surgery is the conventional treatment for a T1 SCC of the lip, where tumor margins can be verified via histologic examination. A histologic margin of less than 2mm is associated with an increased risk of local recurrence and metastasis.

In the Netherlands, surgical treatment of lip carcinomas is performed by dermatologists, plastic and reconstruction surgeons, oral and maxillofacial surgeons (OMFS), and otorhinolaryngologists (ENT). There is currently no international consensus regarding the appropriate surgical margins for excision of a T1 SCC on the lip. According to the AJCC, a surgical margin of 5mm is appropriate, while according to the UICC, a surgical margin of 10mm is appropriate. Scientific evidence is limited regarding differences in tumor clearance and the risk of recurrence or metastasis after excision of T1 SCCs with a surgical margin of 5mm versus 10mm.

We aimed to investigate whether there is a significant difference in tumor-free survival in patients with surgically treated T1 lip SCC with a surgical margin of 5mm versus 10mm.

A retrospective descriptive multicenter data study will be conducted with four different centers in the Netherlands (Maastricht University Medical Center+), Radboud University Medical Center (RadboudUMC) Nijmegen, Catharina Hospital Eindhoven (CZE), and Zuyderland Medical Center Heerlen/Sittard. Data will be obtained from the Dutch Cancer Registry (NKR) and the Dutch Pathological Anatomical National Automated Archive (PALGA).

The primary outcome is the difference in tumor-free survival in patients treated with surgical margins of 5mm and 10mm. The secondary outcome is the difference in tumor-free survival in patients with different histologic free margins. To evaluate the risk of surgical and histologic margins on the risk of local recurrence and metastasis, a Kaplan-Meier analysis, log-rank test and cox-proportional hazard models will be used.

T1 Squamous Cell Carcinomas of the Lip

Tumor Free Survival in T1 Squamous Cell Carcinomas of the Lip Treated With 5mm or 10mm Surgical Margins.

Difference in tumor-free survival of patients treated with a 5mm surgical margin versus 10mm surgical margin for a T1 SCC on the lip. An event was refered to as the occurrence of recurrence or metastasis.

Difference in tumor-free survival of patients with a histologic margin of \<2mm versus patients with a histologic margin of 2mm or more of their T1 SCC on the lip.

Maastricht University Medical Center

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroepithelioma

No intervention. Observation of diffuse reflectance spectroscopy patterna are made on ex-vivo tissue samples in patients undergoing surgery for glial tumors.

Measurements of DRS patterns in extirpated tumor and cerebral tissue

Diffuse Reflectance Spectroscopy

Oscar Persson, MD, PhD

Differentiation between glioma tumor tissue and normal cerebral tissue using Diffuse Reflectance Spectroscopy (DRS) on surgical tissue samples ex-vivo

Background: Diffuse reflectance spectroscopy is an optically based technique which measures the amount of diffusely reflected light after it has undergone multiple scattering and absorption events within the tissue. Each DRS spectrum therefore has a specific 'optical fingerprint' reflecting the composition and morphology of the tissue within the probing volume. The technology is easily built into very small instruments that can be fused with regularly used surgical equipment. DRS has previously been widely investigated for the purpose of margin assessment in other regions of the body.

Aim \& Hypothesis: The primary goal is to show the feasibility of applying optical tissue sensing using diffuse reflectance spectroscopy (DRS) to differentiate healthy cerebral tissue from tumorous tissue in ex vivo human tissue samples. This will be a basis for further development of surgical equipment able to identify the margin between healthy brain tissue and tumor tissue intraoperatively.

Method: Using DRS we aim to determine spectroscopy thresholds that enables differentiation of cerebral tissue from different forms of tumor tissue. We aim to determine these thresholds by collecting DRS data on ex vivo brain and tumor samples. The tumor samples will be part of the normal extraction of tissue during tumor surgeries and the non tumorous tissue can be extracted in temporal/frontal lobe resections as well as epilepsy surgery, where non tumorous brain tissue is to be removed. The DRS measurements are performed in direct connection to the extraction of tissue during surgery, and the tissue is thereafter sent to the pathologist according to standard clinical procedures. No extra tissue will need to be resected for the purpose of this study. Based on the experiments we will propose a theoretical model for differentiating normal cerebral tissue from tumor tissue in humans for use during surgery.

Differentiation Between Healthy Cerebral Tissue and Tumor Tissue Using a Tissue Sensing Instrument

Diffuse Reflectance Spectroscopy pattern in tissue type

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy	NCT03706508	Prostate Cancer Erectile Dysfun... Complication of... Urinary Inconti...	Robot-assisted ...	40 Years - 80 Years	Hospital de Clinicas de Porto Alegre
Efficacy of Optically-guided Surgery in the Management of Early-staged Oral Cancer - COOLS TRIAL	NCT01039298	Oral Cancer High-grade Prec...	Fluorescence vi... Fluorescence vi...	19 Years -	University of British Columbia
A Radiomic Model for Risk of Local Recurrence and DFS for T3 and T4 Non-small Cell Lung Cancer	NCT06405815	Lung Cancer, No...	tumor and perit...	18 Years -	Jinling Hospital, China
Factors Influencing Breast Cancer Resection Volumes And Their Impact on Treatment Outcome (FIBRATIO)	NCT05257577	Breast Cancer Quality of Life Patient Satisfa... Resection Margi... Surgical Margin Multidisciplina...	Breast conservi...	18 Years - 80 Years	Tampere University Hospital
A Radiomic Model for Risk of Local Recurrence and DFS for T3 and T4 Non-small Cell Lung Cancer	NCT06405815	Lung Cancer, No...	tumor and perit...	18 Years -	Jinling Hospital, China
Application of SERS Technology Based Intraoperative Navigation System in Lung Cancer	NCT05881057	Lung Cancer		19 Years - 75 Years	Shanghai Pulmonary Hospital, Shanghai, China
Dermatoscopy Guided Resection for Skin Cancer	NCT06342297	Basal Cell Carc... Cutaneous Squam... Surgical Margin	Dermatoscopy	18 Years -	Region Örebro County
T1 Squamous Cell Carcinomas of the Lip	NCT05610293	Lip Lip Cancer Lip SCC Squamous Cell C... Squamous Cell C... Surgery Surgical Margin Recurrence Metastasis Tumor Free Marg...		18 Years -	Maastricht University Medical Center
Efficacy of Optically-guided Surgery in the Management of Early-staged Oral Cancer - COOLS TRIAL	NCT01039298	Oral Cancer High-grade Prec...	Fluorescence vi... Fluorescence vi...	19 Years -	University of British Columbia
Differentiation Between Healthy Cerebral Tissue and Tumor Tissue Using a Tissue Sensing Instrument	NCT05171127	Glioblastoma Surgical Margin	Diffuse Reflect...	-	Karolinska University Hospital
Differentiation Between Healthy Cerebral Tissue and Tumor Tissue Using a Tissue Sensing Instrument	NCT05171127	Glioblastoma Surgical Margin	Diffuse Reflect...	-	Karolinska University Hospital
T1 Squamous Cell Carcinomas of the Lip	NCT05610293	Lip Lip Cancer Lip SCC Squamous Cell C... Squamous Cell C... Surgery Surgical Margin Recurrence Metastasis Tumor Free Marg...		18 Years -	Maastricht University Medical Center

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