Neoplasms

All Conditions

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

The intervention occurs only one time (for 2h30), the MRI examination is divided as follow:

* Cinicial MRI (50 minutes)
* Research MRI (Phosphorus Spectroscopy, Sodium Imaging)

Diagnostic test

Rémy GUILLEVIN, Pr

Glioma is a tumor of the central nervous system. These lesions are sorted with the WHO ranking regarding the tumoral oncotype. The tumoral MRI assessment is the first step before any medical decision. Currently, only anatomical biopsy can give the tumor grade definition and help to define the most adapted treatment.

Virtual Biopsy Development to Identify Patient's Glioma Grade at the CHU of Poitiers Using Magnetic Resonance Imaging

Evaluate the diagnostic capabilities of artificial intelligence algorithms for virtual biopsy based on sensitivity and specificity

Poitiers University Hospital

Skin and Connective Tissue Diseases

Breast Neoplasms

Inflammatory Breast Neoplasms

Breast Diseases

Skin Diseases

Inflammatory Breast Cancer

One form of breast cancer, known as inflammatory breast cancer (IBC), is characterized by diffuse erythema (redness) and edema (peau d'orange) of the breast. This type of cancer is aggressive and poorly understood. It is rare in the United States (about 4 percent of cases), but more common in Egypt and Tunisia (up to 23 percent of cases). Conducting a case-control study of IBC is complicated by several factors, including the lack of standardized criteria for IBC. In addition, collecting pre-chemotherapy tissue and blood samples from IBC patients is difficult because treatment begins immediately after diagnosis.

In this pilot study, the National Cancer Institute will collaborate with two major cancer centers and two hospitals (in Egypt and Tunisia) to determine the feasibility of a case-control study of IBC. The study will assess the number and characteristics of IBC cases, the feasibility of identifying cases at diagnosis, and the availability of control subjects; will collect frozen pre-treatment tumor tissue from five IBC cases to determine whether RNA isolation is possible; will obtain digital photographs of the breasts of IBC cases; and will demonstrate collaboration between the institutions and personnel involved in the study. The study will last for approximately one year.

Participating hospitals will identify IBC cases. Consenting patients will undergo a breast examination in which the examining surgeon will complete an Initial Examination Form (IEF). Digital photographs of the breasts (but not face) will be taken and linked to the study ID number. Tissue examination results will be entered into the IEF. For five selected cases, additional pre-treatment tumor tissue will be collected and frozen.

This pilot study will assess the availability of controls for a case-control study by investigating the number and type of admissions to the Ear, Nose, and Throat and Ophthalmology Departments at participating hospitals during 2000-2003, using computerized records.

Breast cancer characterized by diffuse erythema and edema, or peau d'orange, of the breast (inflammatory breast cancer (IBC)) is rare, particularly aggressive, and poorly understood. The extent of redness and edema or peau d'orange, of the breast required for a diagnosis of IBC has not been standardized. According to the most recent American Joint Committee on Cancer (AJCC) definition of inflammatory breast cancer, the signs of redness and edema or peau d'orange, should cover the majority of the breast, and should have arisen quickly. Breast cancers with redness and edema or peau d'orange, account for approximately 4 percent of breast cancers in the United States, but up to 23 percent of breast cancers in Egypt and Tunisia.

The proposed pilot study will determine the feasibility of conducting a case-control study of inflammatory breast cancer in collaboration with the National Cancer Institute-Cairo, Egypt, and the Institut Salah Azaiz, Tunis, Tunisia, the major cancer centers in Egypt and Tunisia, and Cairo University Hospital and Charles Nicolle Hospital, affiliated general hospitals from which controls will be selected. Currently, neither case study hospital collects data on the number of inflammatory breast cancer cases meeting the AJCC definition which will be used for the proposed case-control study. In addition, the geographic distribution of IBC cases at the two study hospitals (knowledge of which is necessary for the selection of appropriate controls) is unknown.

The goals of the pilot study are to assess the feasibility of the following critical components of the case-control study: 1) identifying a sufficient number of IBC cases at the time of diagnosis in the two study hospitals; 2) selecting appropriate hospital-based control subjects; 3) collecting frozen pre-treatment tumor tissue; 4) obtaining digital photographs of the breasts of IBC cases; and 5) communicating and working collaboratively with the study hospitals and personnel in Egypt and Tunisia. To accomplish these objectives, IBC cases meeting the AJCC definition as well as cases meeting other definitions of IBC will be identified over a one-year period at each of the two study hospitals. Computerized records at the control hospital for the years 2000-2003 will be used to enumerate the number of female patients with non-chronic diseases (and their age and geographic distribution) in the Departments of Ophthalmology and Ear, Nose and Throat (ENT). Pre-treatment frozen tumor tissue and digital photographs of the breast will be collected from five IBC cases at each study site.

Pilot Study of Inflammatory Breast Cancer in Egypt and Tunisia

National Cancer Institute (NCI)

Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

Immunomodulating Agents

Patients who has received mono-therapy of immune checkpoint inhibitor.

Patients who has received immune checkpoint inhibitor combining chemotherapy.

Clinical: A diagnostic model incorporating clinical variables (Age, Pathological diagnosis, level of serum tumor biomarkers etc.)

Clinical

Semantic: A diagnostic model incorporating semantic radiological features (shape, location, border, density etc.)

Semantic

Radiomic: A diagnostic model incorporating quantitative radiomic features (histogram, texture, morphology etc.)

Radiomic

Zhaoxiang Ye, M.D, Ph.D

This study aims to investigate the feasibility and efficiency of CT radiomic analysis which serves as a high through-put analytical strategy applied to image big-data resource in evaluating and predicting the response of immunotherapeutics. A multi-center retrospective diagnostic test has been designed for this aim to compare the predictive performance of clinical model, qualitative model incorporating semantic CT features and image-based quantitative radiomic model. The reference standard of therapeutic effect is determined by the latest evaluation result utilizing iRECIST within 365 days after recruited. This study intends to enroll 400 participates who had been diagnosed with advanced somatic solid tumor confirmed by histo- or cyto-pathological examination and were planning to receive immunotherapy.

Radiomics of Immunotherapeutics Response Evaluation and Prediction

Radiomics of Immunotherapeutics Response Evaluation and Prediction in Solid Tumor: A Multicenter Diagnostic Study

Area under curve (AUC) of each diagnostic model

Incidence of immune-related adverse events

Tianjin Chest Hospital

Shandong Tumor Hospital

West China Hospital

First Affiliated Hospital of Zhejiang University

Sun Yat-sen University

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Liaoning Tumor Hospital & Institute

Hubei Cancer Hospital

First Affiliated Hospital Xi'an Jiaotong University

Tianjin Medical University Cancer Institute and Hospital

Carcinoma

Carcinoma, Basal Cell

Neoplasms, Basal Cell

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Vasoconstrictor Agents

Respiratory System Agents

Lidocaine

Anesthetics

Epinephrine

Racepinephrine

Epinephryl borate

Immunosuppressive Agents

- Population: Eligible are patients (men and women) ≥18 years of age who visit the outpatient department of dermatology of the Maastricht University Medical Centre because of a clinically suspected BCC.

- Inclusion criteria: All patients aged 18 years or older, otherwise healthy, with ≤ three primary (no previous treatment) clinically determined BCC.

- Exclusion criteria: Patients using immunosuppressive drugs. Genetic skin cancer disorders. Earlier treatments at the same site. Age under 18 years. More than 3 clinical suspected BCCs. Not capable of informed consent.

Punch biopsy is a 10 minutes treatment at the outpatient department of dermatology. Patient will lie down on a bed, the skin will be disinfected and local anaesthesia (lidocaine 1% with epinephrine) will be given, which is briefly painful. Then a PB of 3 mm is taken from the most suspected area. In the case of continuing bleeding the wound will be sutured. A properly taken biopsy will leave no or minimal scarring, but this is not relevant since a SE will be performed afterwards. In very rare cases post-biopsy bleeding or infection occurs.

Punch biopsy

Surgical excision takes place in 30 minutes. Patient will lie down on a bed, the skin will be disinfected and local anaesthesia will be given. sBCC and nBCC will be excised with a 3 mm margin, aBCC with a 5 mm margin. Most BCC can be surgically excised, but some have to be treated with Mohs micrographic surgery (MMS). MMS ensures total BCC removal, preserving as much surrounding skin with 100% margin control. All BCCs will be excised with a 2 mm margin and examined under the microscope. This will totally take 1.5-2.0 hours. If tumour is still present, another tissue layer with 2 mm margin will be excised. It usually takes removal of 1-3 tissue layers to complete MMS.

After both treatments, wounds will be sutured and removed after 1-2 weeks, depending on the localisation. Within the first two weeks posttreatment, patients have to avoid physical heavy movements and keep the suture dry. Possible complications: scarring, continuous or subsequent bleeding, infection and dehiscent wounds.

Surgical excision

Nicole WJ Kelleners-Smeets, MD, PhD

Ellen RM de Haas, MD, PhD

Skin cancer is the most common cancer in Caucasians. Basal cell carcinoma (BCC) is the most frequent skin cancer with around 44.000 new tumours per year in the Netherlands, and its incidence is still rising. Prior to treatment, a punch biopsy (PB) is taken from the suspected lesion, in order to determine the subtype of BCC. There are three different histological subtypes of BCC, from least to most aggressive: superficial, nodular and aggressive. Based on the most aggressive subtype seen in the PB, a suitable surgical margin is chosen. Surgical excision (SE) is the treatment of first choice in all BCC subtypes according to the Dutch guidelines. Recent developments of non-invasive therapies for superficial BCC might be the first choice of treatment in the future. These non-invasive treatments (photodynamic therapy (PDT), Imiquimod and 5-fluorouracil (5-FU)) have better cosmetic results than SE and are therefore also used in the Maastricht University Medical Center. Drawback is a higher recurrence rate than SE. As nodular and aggressive subtypes grow deeper into the dermis, they have to be treated with SE with a 3 mm and 5 mm margin respectively. If BCC are located in the H-zone, the treatment will be Mohs micrographic surgery (MMS). Unfortunately, 30% of subtypes seen in the PB do not correspond with the subtype seen in the subsequent SE/MMS. The consequence is overtreatment and undertreatment. A potential better or equal way to determine the BCC subtype might be the clinical diagnosis. To our knowledge, there is no literature about the diagnostic value of the clinical diagnosis to determine the subtype of BCC seen in the SE/MMS specimen. We want to confirm the hypothesis that the clinical diagnosis is as good as, or even better than the histological diagnosis by PB to determine the BCC subtype in the subsequent SE/MMS. In this case, patients don't have to undergo an extra procedure, diagnostic route is shortened.

- Primary objective: to establish the observed agreement of clinical diagnosis compared to histological diagnosis by to determine the most aggressive subtype of BCC

- Secondary objectives: inter-observer and intra-observer variability of dermatologists and pathologists to determine subtype BCC.

- Basal cell carcinoma throughout the world:

Skin cancer is the most common form of cancer, with basal cell carcinoma (BCC) being the most frequent form of all skin cancers, and the incidence is still rising without future signs of a plateau. Because there is no national registry for BCC in the Netherlands, incidence rates are derived from the only register centre in the southern part of our country. From a recent study we know that approximately 26.625 new patients with BCCs occurred in 2006 in the Netherlands. The average number of BCC per patient is 1.65, resulting in 44.000 new BCCs in that year. With an increase of approximately 10% per year the estimated incidence rate at 2011 will be around 70.800 in the Netherlands. Three important histopathologic subtypes of BCC can be distinguished, namely superficial, nodular and aggressive. In the past, nodular basal cell carcinoma (nBCC) was the most common histopathologic subtype, but superficial basal cell carcinoma (sBCC) and aggressive basal cell carcinoma (aBCC) are the subtypes with the fastest growing incidences. Nowadays, the distribution of histopathologic subtypes of BCC is 40.6% nodular, 30.7% superficial and 28.7% aggressive. The shift from nodular BCCs to other subtypes needs accurate detection of the correct subtype, as treatment per subtype is different. The sharp raising incidence of 10% annually makes BCC an even bigger health problem in the near future.

- Diagnosis of BCC:

BCC is diagnosed with a 3 mm punch biopsy (PB) of the suspected skin lesion. Based on the most aggressive histopathologic subtype seen in this biopsy, an appropriate treatment is chosen. Three subtypes are relevant for a suitable treatment choice: superficial, nodular and aggressive. The last one includes all BCCs with aggressive growth, such as infiltrative/morpheaform BCC, micronodular BCC, and BCC with squamous differentiation. Unfortunately, 31-33% of histopathologic subtypes seen on punch biopsies of primary and recurrent BCCs do not correspond with the subtype seen in the subsequent surgical excision (SE)/ Mohs micrographic surgery (MMS). The consequence is overtreatment and undertreatment.

- Guidelines on the treatment of basal cell carcinoma:

The national advisory board of Dutch dermatologists and plastic surgeons has published multidisciplinary guidelines on the treatment of BCCs in 2007. In these guidelines the different treatment options for all sort of BCCs are discussed and conclusions are drawn for each treatment option. Recommended treatments for all BCCs regardless of the histopathological subtype is SE. Both sBCC and nBCC have to be excised with 3 mm margin while aggressive subtypes need a 5 mm margin. BCCs in the H-zone will be excised with MMS. Photodynamic therapy (PDT), Imiquimod and 5-fluorouracil (5-FU) are also options for sBCC on low-risk sites because of better cosmetic results.Recent studies show overall estimated treatment success at 5-year follow-up of 65% for PDT and 78-80% for Imiquimod. These percentages are far lower than the 99% overall estimated treatment success of SE in sBCC. There is no literature on treatment effect of 5-FU at long term follow-up. Only two studies report 86-87% complete response rate to different 5-FU treatment regimens after 6-12 weeks.

- Treatment of basal cell carcinoma at the Maastricht University Medical Center (MUMC):

In the past, BCC has been a disease of the elderly patient but as a consequence of recreational sun exposure and tanning beds, more young patients develop a skin cancer as well. Therefore, cosmetic results play a more important role when choosing a suitable treatment. Therefore in today's dermatologic practice at the MUMC patients with a sBCC can be treated non-invasively with PDT, Imiquimod, 5-FU or with SE/MMS. These non-invasive treatments show good cosmetic results but higher recurrence rates than SE. Any non-responding or recurrent sBCC has to be retreated with SE/MMS.

- Undertreatment and overtreatment:

Preliminary data from our own study show that in case of a discrepancy between histopathologic BCC subtype in the PB and excision, 58% of patients are overtreated and 42% undertreated. Half of the overtreated patients will have a histological nBCC or aBCC on PB, but only superficial in the SE/MMS. This could be partly due to the fact that the most suspected part has already been biopsied and is not present in surgical excision anymore.

Overtreatment consists of unnecessary tissue loss because of too wide SE margins. In addition, large excisions might lead to more complications like scarring, infection, continued or subsequent bleeding and dehiscent wounds. Undertreated patients have to be re-treated again in case of positive resection margins with SE, resulting in extra stress for patients, time and health care costs.

- Clinical diagnosis:

Histological diagnosis of BCC subtype by PB might not be the perfect procedure because of the 30% mismatch with the subtype seen in the SE/MMS. A potential better way to determine the BCC subtype might be the clinical diagnosis. To our knowledge, there is no literature about the observed agreement of the clinical diagnosis to determine the most aggressive histological subtype of BCC. We want to confirm the hypothesis that the clinical diagnosis is as good as or even better than the histological diagnosis by PB to determine the most aggressive BCC subtype. Confirmation of this hypothesis will result in clinical diagnosis instead of punch biopsies, more patients receiving early and correct treatment, saving time and health care costs. The conclusions from the proposed study can serve as a basis for updating guidelines for the diagnosis of BCC.

A punch biopsy and surgical excision of the BCC will be performed. Both biospecimens will be prepared with either frozen section histology, or paraffin embedded fixed tissue pathology.

Clinical Diagnosis of Basal Cell Carcinoma Subtype

Clinical Diagnosis Versus Histological Diagnosis by Punch Biopsy to Determine the Subtype of Basal Cell Carcinoma

The current proposal aims at establishing the observed agreement of the clinical diagnosis to and histological diagnosis to detect the most aggressive BCC subtype of the entire tumour.

To assess the inter-observer and intra-observer variability of dermatologists and pathologists to determine subtype BCC.

Maastricht University Medical Center

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

video-assisted thoracoscopic surgery

axillary thoracotomy

Hao Long, professor

The purpose of this study is to establish the effects of VATS lobectomy for early-stage non-small cell lung cancer.

The aims of this study are:

1. To evaluate the early clinical benefits of VATS lobectomy when compared with the axillary thoracotomy.
2. To evaluate the late effects of VATS lobectomy on survival and quality of life when compared with axillary thoracotomy.
3. To establish the normative pattern of VATS lobectomy for early-stage non-small cell lung cancer.
4. To explore the indication of VATS lobectomy for the lung cancer.

A Trial on Video-assisted Thoracoscopic Surgery and Axillary Thoracotomy for Resection of Early-stage Non-small Cell Lung Cancer

visual analogue scale and Wong-Baker FACES Pain Rating Scale

operation time, intraoperative blood loss, chest tube drainage amount, duration of the chest tube placement, and duratio

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Virtual Biopsy Development to Identify Patient's Glioma Grade at the CHU of Poitiers Using Magnetic Resonance Imaging	NCT04313140	Development of ... Tumor Grade Artificial Inte... Clinical Radiological	Diagnostic test	18 Years -	Poitiers University Hospital
Virtual Biopsy Development to Identify Patient's Glioma Grade at the CHU of Poitiers Using Magnetic Resonance Imaging	NCT04313140	Development of ... Tumor Grade Artificial Inte... Clinical Radiological	Diagnostic test	18 Years -	Poitiers University Hospital
Pilot Study of Inflammatory Breast Cancer in Egypt and Tunisia	NCT00344071	Inflammatory Br...		-	National Institutes of Health Clinical Center (CC)
Radiomics of Immunotherapeutics Response Evaluation and Prediction	NCT04079283	Solid Tumor Predictive Canc...	Clinical Semantic Radiomic	18 Years -	Tianjin Medical University Cancer Institute and Hospital
Virtual Biopsy Development to Identify Patient's Glioma Grade at the CHU of Poitiers Using Magnetic Resonance Imaging	NCT04313140	Development of ... Tumor Grade Artificial Inte... Clinical Radiological	Diagnostic test	18 Years -	Poitiers University Hospital
Clinical Diagnosis of Basal Cell Carcinoma Subtype	NCT01370824	Basal Cell Carc...	Punch biopsy Surgical excisi...	18 Years -	Maastricht University Medical Center
A Trial on Video-assisted Thoracoscopic Surgery and Axillary Thoracotomy for Resection of Early-stage Non-small Cell Lung Cancer	NCT01102517	Non-small Cell ...	video-assisted ... axillary thorac...	18 Years - 75 Years	Sun Yat-sen University
Clinical Diagnosis of Basal Cell Carcinoma Subtype	NCT01370824	Basal Cell Carc...	Punch biopsy Surgical excisi...	18 Years -	Maastricht University Medical Center
Clinical Diagnosis of Basal Cell Carcinoma Subtype	NCT01370824	Basal Cell Carc...	Punch biopsy Surgical excisi...	18 Years -	Maastricht University Medical Center

Spots Global Cancer Trial Database for clinical

Every month we try and update this database with for clinical cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for clinical

Every month we try and update this database with for clinical cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for clinical cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.