Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Bladder cancer group represents patients attending or hospitalized in Urology department, Reims University Hospital and in whom, tumor is visualized during cystoscopy and confirmed by the histological examination of entire resected lesion after Trans Urethral Resection of Bladder Tumor (TURBT).

Control group includes patients consulting for cystoscopy examination in Urology department, Reims University Hospital without any tumor visualization during cystoscopy examination.

Urine vibrational analysis

Stéphane LARRE

This study aims to evaluate the performance of vibrational spectroscopy (Infrared and Raman spectroscopy techniques) in bladder cancer diagnosis using urine samples.

Urologic cancers affect the organs and structures of the male and female urinary tract and the male reproductive system. Bladder cancer (BCa) is the second urological cancer in incidence after prostate cancer and represents the 10th most common cancer in the world. This cancer has high recurrence and progression rates. Cystoscopy and urine cytology are the current gold-standard examination for bladder cancer. Nevertheless, the first is invasive and the latter has low sensitivity especially for low-grade bladder cancer. Therefore, it is critical to implement accurate, non- invasive and sensitive examination tool to diagnose patients with bladder cancer at an early stage.

On the one hand, urine is collected non-invasively and considered as a proximal biofluid from bladder. On the other hand, vibrational spectroscopy including Infrared and Raman spectroscopy is widely used for the analysis of biological samples and provides a molecular fingerprint of the sample with minimum or no sample preparation. Applied on urine, this technique may offer interesting alternative for bladder cancer diagnosis and monitoring. Hence, this research project aims to evaluate the analytical capabilities of urinary vibrational spectroscopy with the objective of developing a diagnostic test for urothelial bladder cancer.

The study is planned for 36 months. Patients that approve their participation in the study will respond to a questionnaire allowing us to have clinical information. From these patients, urine samples will be collected in Urology department of Reims University Hospital. Urine samples will be directly analyzed by Fourier Transform Infrared Spectroscopy and/or Surface-enhanced Raman spectroscopy then stored at -80°C for further analysis.

Urinary Markers by SpectrosCopy: Diagnostic Aid in oncologY - Application to Urological Cancers

Urinary Markers by SpectrosCopy: Diagnostic Aid in oncologY - Application to Urological Cancer

Analyze urine samples by infrared spectroscopy after drying step and without any further sample preparation. The obtained spectra will be preprocessed and analyzed by multivariate algorithms to discriminate bladder cancer patients from control group.

Analyze urine samples by Surface-enhanced Raman spectroscopy after mixing urine samples with silver nanoparticles. The obtained spectra will be preprocessed and analyzed by multivariate algorithms to discriminate bladder cancer patients from control group.

CHU de Reims

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 same sample is diagnosed using a Raman analyzer firstly and then diagnosed by paraffin pathology.

Perform two diagnostic methods on the same sample

Paraffin pathological diagnosis

Tao Jiang, MD and PhD

Yinyan Wang, MD and PhD

Qing Mao

Dongming Yan

Shouwei Li

Compare the data obtained from the Raman analyzer and paraffin pathology examination on the same external brain tissue sample. Evaluate the effectiveness and safety of the Raman analyzer for intraoperative diagnosis gliomas of brain resection tissue samples, using paraffin pathological examination results as clinical reference standards.

Based on statistical calculations,108 positive samples and 148 negative samples will be included in the trial in all trial centers. Compare the results between the Raman analyzer and the paraffin pathological. And calculate the sensitivity, the specificity, and other indicators of Raman analyzer.

During surgery, core or marginal tissue samples were taken from subjects. The test samples size:0.2cm\<length diameter ≤ 2cm. The sample testing result is based on the Raman test points. Then take the same tissue sample for paraffin pathological diagnosis.

Statistical description of all data, including baseline data, all efficacy indicators, and all safety data. The measurement data give the mean, standard deviation, minimum, maximum, median,25 quantile and 75 quantile; Provide frequency and composition ratio for counting data. The baseline data was analyzed using the Full Analysis Set (FAS); The effectiveness analysis adopts FAS and PPS; The security analysis uses the Security Dataset (SS).

The same sample was diagnosed using Raman spectroscopy and paraffin pathology, respectively. Calculate the sensitivity and specificity of a Raman analyzer using paraffin pathological results as the gold standard.

Blind assessment: Researchers using Raman analyzer during surgery are not aware of the subjects' preoperative diagnostic results, while researchers conducting paraffin pathology examinations after surgery are not aware of the subjects' preoperative diagnostic results and the diagnostic results of Raman analyzer.

Evaluate the Accuracy of Raman IVD Analyzer in the Diagnosis of Gliomas During Surgery

Evaluate the Effectiveness and Safety of the Raman IVD Analyzer for Intraoperative Glioma Diagnosis, Using Samples From Brain Resection Tissue (Prospective, Multicenter, Blind Evaluation, Single Group Target Value Method)

The proportion of subjects with defects in the Raman analyzer during normal use to the total number of subjects using the Raman analyzer

Number of subjects with AE/total number of subjects ×100%

Number of subjects with SAE/total number of subjects ×100%

Possible damage to device operators during the use and maintenance of the Raman analyzers

Among the samples determined by paraffin pathology as gliomas, the percentage of samples detected by Raman analyzer as gliomas.

Among the samples determined by paraffin pathology as non gliomas, the percentage of samples detected by the Raman analyzer as non gliomas.

The proportion of tissue samples with consistent results between Raman analyzer detection and paraffin pathological diagnosis.

The percentage of samples diagnosed with glioma by paraffin pathology in the samples detected as glioma by Raman analyzer

The percentage of samples diagnosed with non glioma by paraffin pathology in the samples detected as non glioma by Raman analyzer

Kappa coefficient≥0.75 indicates high consistency; 0.75\>Kappa coefficient≥0.4, considered consistent; If the Kappa coefficient is less than 0.4, it is considered inconsistent.

Time required from emitting laser to completing single point detection

West China Hospital

The First Affiliated Hospital of Zhengzhou University

Capital Medical University

Jiangsu Raman Medical Equipment Co., Ltd.

Beijing Tiantan Hospital

Perform the diagnosis of Raman analyzer and immunohistochemistry or genetic test on the same sample.

Immunohistochemistry or genetic test

Wang Yinyan, MD and PhD

To distinguish various molecular subtypes of gliomas by spectra data obtained from Raman analyzer, including IDH mutant, 1p/19q-codeleted, ATRX deletion, TERT promoter mutation, MGMT promoter methylation, EGFR amplification, H3 K27-altered, TP53 mutant, PTEN deficiency, ki 67, AQP4, VEGF, and so on, comparing with the results of Immunohistochemistry or genetic test on the same brain tissue samples.

1500 samples were included retrospectively with the spectra data obtained from Raman analyzer to establish clinical intelligence model, modifying the analyzer. Based on statistical calculations, 200 glioma samples will be included in the trial in all trial centers prospectively. Compare the results between the Raman analyzer and Immunohistochemistry or genetic test results. And calculate the AUC, the accuracy, sensitivity, the specificity, and other indicators of Raman analyzer.

During surgery, core tissue samples were taken from subjects. The test samples size:0.2cm\<length diameter ≤ 2cm. The sample testing result is based on the Raman test points. Then take the same tissue sample for Immunohistochemistry or genetic test.

Statistical description of all data, including baseline data, all efficacy indicators, and all safety data. The measurement data give the mean, standard deviation, minimum, maximum, median,25 quantile and 75 quantile; Provide frequency and composition ratio for counting data. The baseline data was analyzed using the Full Analysis Set (FAS); The effectiveness analysis adopts FAS and PPS; The security analysis uses the Security Dataset (SS).

The same sample was diagnosed using Raman spectroscopy and immunohistochemistry or genetic test, respectively. Calculate the AUC, the accuracy, the sensitivity and specificity of a Raman analyzer using immunohistochemistry or genetic test results as the gold standard.

Blind assessment: Researchers using Raman analyzer during surgery are not aware of the subjects' preoperative diagnostic results, while researchers conducting immunohistochemistry or genetic test after surgery are not aware of the subjects' preoperative diagnostic results and the diagnostic results of Raman analyzer.

Evaluate the Effectiveness and Safety of Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery

Evaluate the Effectiveness and Safety of the Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery, Using Samples From Brain Resection Tissue (Ambispective, Multicenter, Blind Evaluation, Single Group Target Value Method)

The Area Under the Curve of the ROC curve illustrates the performance of Raman analyzer for the diagnosis of molecular subtype in glioma, confirmed by immunohistochemistry or genetic test.

The proportion of tissue samples with consistent results between Raman analyzer detection and immunohistochemistry or genetic test.

Among one kind of molecular subtype samples determined by immunohistochemistry or genetic test, the percentage of samples detected by Raman analyzer as the same molecular subtype.

Among one kind of molecular subtype samples determined by immunohistochemistry or genetic test, the percentage of samples detected by Raman analyzer as the different molecular subtype.

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Precancerous Conditions

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

participants with normal benign nodules (no cancer)

participants with follicular thyroid cancer

participants with papillary thyroid cancer

participants with anaplastic thyroid cancer

participants with medullary thyroid cancer

routine surgical removal of thyroid for biopsy

thyroid lobectomy

The measurement of Raman spectra from the excised tissue

Raman spectroscopy probe measurement

Julia Hall

Alexander P Dudgeon, PhD

Catherine A Kendall, PhD

Charlie Hall, MBBS

Maryam Nowghani

Ex vivo vibrational spectroscopy (VS), including Raman spectroscopy (RS) of thyroid tissue samples, collected from patients undergoing routine diagnostic thyroid biopsies for diagnosis of potential thyroid cancer. Raman spectra are to be correlated with consensus histopathology and clinical outcomes. Multivariate analysis to be used to evaluate the classification accuracy of VS ex vivo.

The Investigators (The Biophotonics Research Unit, University of Exeter and University of Bristol) have developed these "smart needle" probes, consisting of fibre-optics within a fine needle for investigating cancer below the skin's surface. It is difficult to create a sensitive probe to fit inside a needle; however, The Investigators have demonstrated this approach in lymph node tissue samples from 68 patients in the laboratory, where The Investigators showed that our probe could detect cancer with a high level of accuracy.

Following on from our success with lymph nodes The Investigators wish to trial our smart needle on excised thyroid to demonstrate the device in another ENT cancer. Earlier studies have shown that thyroid cancer can be diagnosed using RS under a microscope with an accuracy greater than 78%.9 By eliminating the need for unnecessary surgery by diagnosis with our device, The Investigators will minimise the risk to patients, eliminate delays in obtaining results and reduce the cost of surgery and overnight stay in the hospital. The Investigators wish to advance this device closer to the clinic for a new cancer to improve the patient care pathway and remove the need for unnecessary surgery, by facilitating the work of the one-stop ENT diagnostic outpatient clinics.

The study consists of measuring spectra of new tissue taken during routine diagnostic surgical thyroid lobectomy.

New tissue for this project will be collected during routine biopsy will be rapidly analysed by a spectrometer before proceeding with conventional histopathological analysis. The new tissue will consist of thyroid and adjacent tissue biopsies. No additional tissue will be taken for this research, The Investigators only plan to measure samples taken during routine diagnosis in under 5 minutes, before passing the sections back to the surgical team for routine histopathological analysis.

Anonymous background information relevant to known risk factors, family history and details of any treatment, menopausal status, details relevant medical procedures, and any treatment for thyroid cancer will be provided with the samples. An example of the report can be found in Appendix 3. Tissue specimens taken during routine clinical care are to be subjected to ex vivo vibrational spectroscopic analysis immediately prior to being sent for routine histopathological analysis. Vibrational spectra are to be correlated with consensus histopathology of adjacent sections. Multivariate analysis is to be used to evaluate the classification accuracy of VS ex vivo. The vibrational spectra will be assessed for both prognostic as well as diagnostic information.

RAman For Thyroid cancER

Evaluation of the Role of Vibrational Spectroscopy in the Diagnosis of Premalignant and Malignant Disease of the Thyroid RAFTER (RAman For Thyroid cancER)

Pathology reports will be linked using a pseudo-anonymous unique study identifier

Measure Raman spectra and match with histopathology. Perform leave-one-out analysis to measure performance of diagnosis of Raman spectroscopy

Diagnostic performance (specificity and sensitivity) of Raman spectroscopy (RS) for differentiation of thyroid cancer vs normal benign (no cancer).

Diagnostic performance of RS for differentiation of thyroid cancer types.

* Papillary thyroid cancer
* Follicular thyroid cancer
* Anaplastic thyroid cancer
* Medullary thyroid cancer

Gloucestershire Hospitals NHS Foundation Trust

Post-Doctoral Research Fellow

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

patients diagnosed with non-hodgkin lymphoma

patients diagnosed with squamous cell carcinoma

patients diagnosed with a reactive (non-cancerous) lymph node

none of the above. Other cancer and non-cancer conditions

measurement of the tissue with spectroscopy

spectroscopic measurement

a fine needle aspiration (FNA) biopsy will be taken

FNA biopsy

Histopathology and cytology will be performed on the samples

histopathology and cytology

Antony Walsh

Charlie Hall

Nick Stone

Lymphoma diagnosis often involves removal and biopsy of one or more lymph nodes. Many (around half) of these diagnostic procedures show that no cancer is present, hence unnecessary removal results in numerous side effects and complications. The procedure is also highly invasive.

The investigators have already shown that it is possible to tell the difference between healthy and diseased tissue in the laboratory by looking at the light emitted by tissue when a low power laser is shone on to it. The investigators intend to use this technique, known as "Raman Spectroscopy" (RS) to tell if tissue in the node is cancerous or healthy. By combining RS with a fine needle, the technique can target tissues below the skin with minimal invasion. Our needle will provide the clinician with instant diagnosis without the delay and cost of a laboratory analysis by pathologists.

The investigators have designed a probe that slides through a fine needle, guided by ultrasound, to the lymph node. The space between the two needles provides space for cell aspirate.

The investigators propose to measure spectra from excess lymph node biopsy samples taken during standard routine diagnostic biopsy.

The investigators are also interested to see if they can successfully extract a fine needle aspiration (FNA) biopsy sample using the device, as well as record a RS measurement. If successful this would ease clinical adoption as the study could run in parallel with existing standard routine clinical practice, using just one device.

This study will evaluate the new device on half a lymph node that will be excised and snap-frozen during a routine surgical biopsy, to gather data for submission of approvals for an in-vivo study to follow.

Surplus lymph node tissue collected from patients undergoing routine surgical treatment for head \& neck disease will be investigated using vibrational spectroscopy.

The project will develop a combined FNA/Raman spectroscopy needle probe. This study will evaluate this device on excised lymph node tissue to gather data for submission of approvals for an in-vivo study to follow. Raman \& FTIR (fourier transform infrared) spectra will be correlated with routine histopathology results using multivariate analysis methods. Cytology samples taken using the device will be compared with histopathology results.

Aims

To demonstrate that the FNA/Raman spectroscopy probe device, developed as part of this project, can:

Safely perform measurement of Raman spectra on excised lymph node tissue Safely perform FNA (fine needle aspiration) biopsies on excised lymph node tissue To evaluate the performance of a Raman needle probe to detect lymphoma \& malignancy in excised head \& neck lymph nodes and differentiate from benign nodes.

To develop the investigators understanding of vibrational spectroscopy signal characteristics in head \& neck lymph nodes (through Raman \& FTIR mapping measurements of tissue sections).

Objectives To test a new combined FNA and spectroscopic device on ex vivo tissue in preparation for an in vivo study.

Outcome

Primary Outcome Measures The FNA/Raman spectroscopy probe device can be used safely on excised lymph nodes to measure tissue spectra and collect FNA biopsies.

Diagnostic performance of vibrational spectroscopy for differentiation of lymphoma \& malignant nodes from benign nodes.

Secondary Outcome Measures Evaluation of the performance of a Raman needle probe to detect lymphoma \& malignancy in excised head \& neck lymph nodes and differentiate from benign nodes. To develop the investigators understanding of vibrational spectroscopy signal characteristics in head \& neck lymph nodes (through Raman \& FTIR mapping measurements of tissue sections).

Evaluation of the performance of a Raman needle probe to measure head \& neck lymph nodes (ergonomic design, ease of use etc.).

DOLPHIN-VIVO: Diagnosis Of LymPHoma IN Vivo (In Vivo Phase)

Diagnosis Of Lymphoma In Vivo Using Vibrational Spectroscopy (In Vivo Phase)

Unique study number and MRN (medical records number) (hospital number)

Testing of the device for clinical application during surgery to demonstrate its use is safe and that is able to acquire diagnostic-quality spectra in less than 5 seconds from lymph nodes.

Computer model using multivariate analysis able to discriminate between diseased and non-diseased tissue. The target specificity and sensitivity are low due to small study group sizes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Urinary Markers by SpectrosCopy: Diagnostic Aid in oncologY - Application to Urological Cancers	NCT06087016	Urinary Bladder...	Urine vibration...	18 Years -	CHU de Reims
Urinary Markers by SpectrosCopy: Diagnostic Aid in oncologY - Application to Urological Cancers	NCT06087016	Urinary Bladder...	Urine vibration...	18 Years -	CHU de Reims
Evaluate the Accuracy of Raman IVD Analyzer in the Diagnosis of Gliomas During Surgery	NCT05901844	Glioma	Paraffin pathol...	18 Years -	Beijing Tiantan Hospital
Evaluate the Effectiveness and Safety of Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery	NCT06363162	Glioma	Immunohistochem...	-	Beijing Tiantan Hospital
Evaluate the Accuracy of Raman IVD Analyzer in the Diagnosis of Gliomas During Surgery	NCT05901844	Glioma	Paraffin pathol...	18 Years -	Beijing Tiantan Hospital
RAman For Thyroid cancER	NCT04040673	Thyroid Disease... Thyroid Cancer	thyroid lobecto... Raman spectrosc...	18 Years -	Gloucestershire Hospitals NHS Foundation Trust
Evaluate the Effectiveness and Safety of Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery	NCT06363162	Glioma	Immunohistochem...	-	Beijing Tiantan Hospital
DOLPHIN-VIVO: Diagnosis Of LymPHoma IN Vivo (In Vivo Phase)	NCT05010369	Lymphoma Head and Neck C...	spectroscopic m... FNA biopsy histopathology ...	18 Years -	University of Exeter

Spots Global Cancer Trial Database for raman

Every month we try and update this database with for raman 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.

Spots Global Cancer Trial Database for raman

Every month we try and update this database with for raman 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 raman 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.