Neoplasms

All Conditions

Digestive System Diseases

Adenocarcinoma

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Patients will undergo:

* Conventional rectoscopy
* pCLE exam following injection of fluorescein, fluorescent contrast agent
* EUS : echoendoscopy
* Biopsies for histopathology : location identical to those of pCLE
* Tumor resection will be performed according to standard oncologic principles.

All visible lesions will be documented. Both healthy and tumor tissue will be examined. Location of sites of interest will be documented on a schema, completed with photographs of endoscopic view.

Biopsies will be harvested in both healthy and tumor tissue as well.

After all procedures are complete, a second assessment of pCLE images by a third party will be performed.

Probe-based confocal laser endomicroscopy

Patients will undergo:

* Conventional rectoscopy
* pCLE exam following injection of fluorescein, fluorescent contrast agent
* EUS : echoendoscopy
* Biopsies for histopathology : location identical to those of pCLE - Tumor resection will be performed according to standard oncologic principles.

All visible lesions will be documented. Both healthy and tumor tissue will be examined. Location of sites of interest will be documented on a schema, completed with photographs of endoscopic view.

Both healthy and tumor tissue will be examined.

Rectoscopy

Patients will undergo:

* Conventional rectoscopy
* pCLE exam following injection of fluorescein, fluorescent contrast agent
* EUS : echoendoscopy
* Biopsies for histopathology : location identical to those of pCLE - Tumor resection will be performed according to standard oncologic principles.

All visible lesions will be documented. Both healthy and tumor tissue will be examined. Location of sites of interest will be documented on a schema, completed with photographs of endoscopic view.

Patients will undergo:

* Conventional rectoscopy
* pCLE exam following injection of fluorescein, fluorescent contrast agent
* EUS : echoendoscopy
* Biopsies for histopathology : location identical to those of pCLE
* Tumor resection will be performed according to standard oncologic principles.

All visible lesions will be documented. Both healthy and tumor tissue will be examined. Location of sites of interest will be documented on a schema, completed with photographs of endoscopic view.

Biopsies will be harvested in both healthy and tumor tissue as well.

Biopsy and resection

Joël Leroy, Pr

This innovative study will involve the use of probe-based confocal laser endomicroscopy, a new medical imaging technology never used for surgical indications to date. Virtual biopsies (pCLE images) will be compared to histopathology analysis.

This study focuses on the evaluation of rectal tumor margins. The hypothesis is that pCLE will allow identification of rectal tumor margin, comparable to that of histopathology. In the future, decision of resection margin could rely on intraoperative pCLE exam.

The proposed study is a feasibility study, first in the indication of rectal cancer.

Defining the limits of resection of rectal tumors is often imprecise. The identification of the banks of a tumor becomes critical when it comes to the decision to potentially sacrifice the sphincter during the surgical resection. Currently tumor margins are identified by direct examination by the surgeon, or using flexible endoscopy. Endoscopy and confocal microscopy could provide precise images of tumor enabling the reliable definition of resection margins.

There would be a direct benefit for the patient, whom sphincter could be preserved. pCLE (probe-based Confocal Laser Endomicroscopy) has already been widely used for colorectal lesions, and its value proposition has been demonstrated and validated in several studies. This study is the first using pCLE intraoperatively. Study results may lead the use of pCLE to validate surgical procedure decision (resection margin) and to a revision of patient management for colorectal cancer, by adapting neoadjuvant radiochemotherapy to the patient's responder status.

The goal is to identify tumor margin (lower pole) to optimize the resection margin, and to limit resection of healthy rectal tissue for optimal anal sphincter preservation. Moreover, determining the optimal date of surgery following neoadjuvant radiochemotherapy in rectal cancer is being discussed and no consensus has been reached. Therefore, to date, there is no formal evaluation of tumor response. This is partly due to the lack of information on tumor state and tumor evolution over time, between the end of radiochemotherapy and surgery. Histological follow up of tumor would provide supporting information to fill this gap. However, frequent tumor biopsies are not possible. Alternatively, probe-based confocal laser endomicroscopy (pCLE) could allow for a sequential analysis of tumor response. Response to treatment could be assessed and used to define optimal date of surgical resection, depending on patient responding status to treatment. Responding patients would undergo surgery at a later date than non-responders, in whom surgery could be performed earlier.

Benefits of the study lay in the more accurate definition of resection margins, with its associated potential therapeutic impact of the anal sphincter preservation and in the definition of the optimal date of rectal tumor resection, based on response status to radiochemotherapy.

Study interests are :

* Microscopic structure of tumor will be analyzed at the cellular and microvascular levels and compared to healthy mucosa.
* Evolution of response during and following radiochemotherapy will be assessed, and will help classify patients as responders/non responders.
* pCLE results will be compared to histopathology results on pre-treatment and resection biopsies.
* Images gathered through the imaging modalities (WLE, pCLE, EUS) along with histopathology results will be combined to create an atlas and database of rectal tumors.

Evaluation of Rectal Tumor Margin Using Confocal Endomicroscopy and Comparison to Histopathology

Identification of lower pole of tumor will be compared between pCLE (optical images, virtual biopsies) and conventional histopathology (biopsies, postoperative analysis of resected piece). Samples of tumor tissue and closest tissue thought to be disease-free.

Conventional biopsies and virtual biopsies prior to radiochemotherapy start (if applicable) and during surgery.

Microvascularisation density, general microstructure, image interpretation criteria, true/false positive/negative.

Will be assessed for all patients at the time of surgical procedure. Also prior to treatment for patients undergoing radiochemotherapy.

Evaluation of concordance between pCLE and conventional histopathology for :

* tissue characterization prior to and after radiochemotherapy, if applicable
* radiochemotherapy response assessment
* resection margin evaluation

For patients undergoing radiochemotherapy, 2 exams: prior to treatment start and during surgery For patients with surgery only, 1 exam: during surgery

pCLE results will be compared to EUS prior to radiochemotherapy and at the time of resection.

Creation of an image bank : identification of quality and safety criteria to be of interest for use at the time of resection

Results will be analyzed to assess whether pCLE interpretation criteria have a predictive value for identification of responder/non-responders patients to radiochemotherapy.

IHU Strasbourg

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

In addition to standard workup and treatment, patients will undergo pre-operatively, after induction of general anaesthesia, an endorectal ultrasound and rigid rectoscopy as study procedures if these are not part of standard workup yet.

Ultrasound

For some patients, images of the resection specimen (note: NOT of the patients) during the pathological process will be acquired.

Scan, e.g. CT (resection specimen)

Maaike Berbée, MD, PhD

Evert Van Limbergen, MD, PhD

Jarno Melenhorst, MD, PhD

An-Sofie Verrijssen, MD

Pim Burger, MD, PhD

The aim of the study is to provide prospective data regarding microscopic tumor spread in all directions from the macroscopic tumor in pathology specimens, as seen by eye, and on imaging to define the target volume for endoluminal radiation boosting in rectal cancer patients.

This study is a prospective multicentre cohort trial in ≥50 patients with a residual ycT1-3N0 tumor after neoadjuvant chemoradiotherapy or radiotherapy for rectal adenocarcinoma at least 6 weeks after the neoadjuvant treatment.

In addition to standard workup and treatment (e.g. a flexible endoscopy and an MRI scan at 6-8 weeks post-neoadjuvant therapy), patients will undergo pre-operatively, after induction of general anaesthesia, an endorectal ultrasound and rigid rectoscopy as study procedures if these procedures are not already part of standard workup. Furthermore, the pathological specimens of some patients will be scanned using MR imaging during certain parts of the pathological process.

Objectives include determining the maximum distance of microscopic tumor spread per patient in all directions, creating a tissue deformation model to account for changes due to e.g. fixation and pathological processing, using this tissue deformation model to translate the microscopic tumor spread back to the in vivo situation (e.g. back to in vivo MRI scans, 3D endo-ultrasounds), and evaluating/determining risk factors for the presence and/or extent of microscopic tumor spread.

This data will be used for target volume definition in rectal endoluminal radiation boosting.

* The (re)biopsy material
* (Part of) the material of the pathological rectal specimen after TME surgery

Both are part of standard clinical care.

DETECT: Target Volume for Rectal Endoluminal Radiation Boosting

DETECT: Defining the Target Volume for Endoluminal Radiation Boosting in Patients With Rectal Cancer

The data will not be shared with other researchers, however the following applies if patients have given specific, additional consent:

If patients have consented to the use of leftover body material and/or data in further studies, the deidentified images (endoscopy, rectoscopy, ultrasound, in vivo MRIs and specimen MRIs) and pathological specimens/samples including (re)biopsies, and the accompanying data can be used for further scientific research related to rectal cancer by the investigators, including investigators from collaborating institutions, without requiring additional informed consent.

Potential risk factors include among others ycT stage, regrowths/local recurrence, diameter, predominant histologic grade, tumor regression score/grade (pathologically), vascular invasion, lymphatic invasion, perineural invasion, microsatellite instability (MSI) and parameters related to in vivo MR imaging.

This includes the biopsy material at time of diagnosis, and also the rebiopsy material for patients with tumor regrowths/local recurrence after an initial clinical complete response and a "watch and wait" approach. These (re)biopsies are a part of the standard diagnostic work-up. Part of this analysis will be performed during this study by reassessment of the histology of the biopsy material and/or if applicable the rebiopsy material.

The maximum distance of microscopic tumor spread in all directions from the macroscopic remnant in the specimen will be measured per patient in millimeters by the pathology department in the pathologic resection specimens.

Measured per patient in millimeters by the pathology department in the pathologic resection specimens. Microscopic tumor spread perpendicular to the bowel wall and parallel to the bowel wall will be reported separately.

Measured per patient in millimeters by the pathology department in the pathologic resection specimens. For this secondary outcome, this will be reported excluding all ypT0 patients.

Measured per patient in millimeters by the pathology department in the pathologic resection specimens. For this secondary outcome, this will be reported only for patients with microscopic tumor spread.

Measured per patient in millimeters by the pathology department in the pathologic resection specimens. For this secondary outcome, this will be reported only for patients with regrowths.

The deidentified images of the flexible endoscopy and in vivo MRI scan will be collected for the study. During the certain parts of the pathologic process, e.g. before and after fixation, MRIs of the pathological specimens of some of the patients will be made. These deidentified images of the specimens, together with e.g. the deidentified endoscopic, rectoscopic, ultrasound and in vivo MR images and possibly with optical images taken during pathological analysis, will be used to develop the deformation model.

The flexible endoscopy and in vivo MRI scan are both taken approximately 6-8 weeks post-neoadjuvant treatment. The images of the rigid rectoscopy and 3D endorectal ultrasound are taken directly before TME surgery.

The tissue deformation factor/model and the location of the microscopic tumor spread in relation to the macroscopic remnant determined during pathological analysis, will be used to determine the maximum distance of microscopic tumor spread in relation to the macroscopic tumor as seen by eye (rectoscopically/endoscopically) and/or on imaging (endo-ultrasound, MRI) per patient in all directions.

The flexible endoscopy and in vivo MRI scan are both taken approximately 6-8 weeks post-neoadjuvant treatment. The images of the rigid rectoscopy and 3D endorectal ultrasound are taken directly before TME surgery.

Distance that covers the microscopic tumor spread in all directions in millimeters for 90 and 95% of patients, including 95% confidence intervals, both reported including and excluding ypT0 patients. Reported both by eye and on imaging, for which among others the tissue deformation model will be used.

These risk factors include pathological T stage after chemoradiation (ypT stage) and time interval between neoadjuvant chemoradiotherapy and surgery.

Maastricht University Medical Center

Catharina Ziekenhuis Eindhoven

Maastricht Radiation Oncology

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients will have new biopsy before starting RT-CT and samples will be taken on rectum surgery at the level of the tumor and away from the rectum.

Biopsy

Pascale MARIANI, LDD

Single center interventional study to explore activity of fibroblasts in the tumor and away in the healthy rectal tissue.

Patients included in the trial will have new biopsy performed before starting the Radiation Therapy and Chemotherapy (RT-CT). These biopsies will study the activity of fibroblasts in the tumor and away in the healthy rectal tissue. Within 8 to 10 weeks after the end of RT-CT, patients will have cancer surgery by proctectomy (with complete removal of the meso-rectum). On the resection specimen, new samples will be taken at the level of the tumor and away from the rectum.This study is single center interventional exploratory .

Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma

Interest in Studying Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma : Exploratory Study

Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.

On a mouse model of orthotopic rectal cancer, assessment of the potential and metastatic tumor growth

Histological response after RT-CT assessed according to the tumor regression grading - Dworak 1997

Proteomic level is assessed before and after radiochemotherapy using SILAC technic (Stable Isotope Labeling by Amino acids in Cell culture)

In vitro analysis including tumor cells characteristics: proliferation, invasive potential, stem cells phenotype).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Rectal Tumor Margin Using Confocal Endomicroscopy and Comparison to Histopathology	NCT01887509	Rectal Cancer Rectal Adenocar...	Probe-based con... Rectoscopy EUS Biopsy and rese...	18 Years -	IHU Strasbourg
DETECT: Target Volume for Rectal Endoluminal Radiation Boosting	NCT04927897	Rectal Cancer	Ultrasound Rectoscopy Scan, e.g. CT (...	18 Years -	Maastricht Radiation Oncology
Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma	NCT02849158	Rectum Adenocar...	Biopsy	18 Years -	Institut Curie
DETECT: Target Volume for Rectal Endoluminal Radiation Boosting	NCT04927897	Rectal Cancer	Ultrasound Rectoscopy Scan, e.g. CT (...	18 Years -	Maastricht Radiation Oncology
Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma	NCT02849158	Rectum Adenocar...	Biopsy	18 Years -	Institut Curie

Spots Global Cancer Trial Database for rectoscopy

Every month we try and update this database with for rectoscopy 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 rectoscopy

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