Development of a Clinical and Biological Database in Rectum Cancer (BCBRectum)

November 3, 2021 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Development of a Monocentric and Prospective Clinical and Biological Database in Rectum Cancer

A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to Rectum Cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In France, colorectal cancer is the second major cause of cancer-related death with 17 000 cases per year. Rectal carcinoma represents 40% of colorectal cancers.

Locally advanced rectal carcinoma raises the issue of both the oncological control, local and general, and the therapeutic morbidity. Currently, pre-operative radiochemotherapy associated with radical proctectomy (TME) is the standard treatment. Radiochemotherapy improves the local control but with enhanced postoperative morbidity and poor functional results.

Moreover, some patients have no downstaging (around 1/3) and the metastatic risk remains about 30%.

Then, compliance to adjuvant chemotherapy is generally poor after radical proctectomy.

Tumor response to preoperative treatment is the major prognostic factor which reveals tumor aggressiveness. Nevertheless, at present, there are no predictive markers of tumor response.

Progresses in rectal cancer management are related to sharing biological and clinical resources with scientific community.

A clinical and biological collection will allow to :

  • develop research programs on predictive markers to pre-operative radiochemotherapy or prognostics factors to disease recurrence
  • optimize diagnostic and follow-up tests
  • develop new biomarkers to improve patient's therapeutic management

In this context, the Montpellier Cancer Institute (ICM) decided to initiate a biological collection biomedical research dedicated to the tissular and blood samples of patients with colorectal cancer.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient treated at the Montpellier Cancer Institute, whatever the treatment received (systemic cancer treatment or radiotherapy or surgery)
  • Age > 18 years
  • Signed informed consent

Exclusion Criteria:

  • Patient not affiliated to Social Protection system
  • Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
  • Patient under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biological collection

For all the patients include in the study :

  • Paraffin tissue samples (if applicable) collected during pre-therapeutic rectal biopsy
  • Blood samples collected at different times : Before any treatment and Before surgery if the patient received pre-operative radiochemotherapy

In parallel to this biological collection, standardized clinical data will be entered into a database
Other: Biological collection

Blood samples are collected at different times :

  • Before any treatment
  • After pre-operative radiochemotherapy and before surgery (if applicable)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who gave their consent to participate in the study
Time Frame: Until the study completion : 66 months
The proportion of patients who consent to participate in the study among the screened patients
Until the study completion : 66 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: ROUANET Philippe, MD-PhD, Institut régional du Cancer Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2014

Primary Completion (Anticipated)

July 1, 2026

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

November 3, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM-BCB-2014/02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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