Development of a Clinical and Biological Database in Rectum Cancer

NCT ID: NCT04006951

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-08
• Study Completion Date: 2026-12-31

Brief Summary

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.

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.

Conditions

Rectal Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Biological collection

Intervention Type: OTHER

Blood samples are collected at different times :

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

Interventions

Biological collection

Blood samples are collected at different times :

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ROUANET Philippe, MD-PhD

Role: STUDY_CHAIR

Institut régional du Cancer Montpellier

Locations

ICM Val d'Aurelle

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Aurore MOUSSION

Role: CONTACT

drci-icm105@icm.unicancer.fr

4 67 61 31 02 ext. +33

Facility Contacts

Philippe ROUANET

Role: primary

philippe.rouanet@icm.unicancer.fr

00467613100

References

Haustermans K, Debucquoy A, Lambrecht M. The ESTRO Breur Lecture 2010: toward a tailored patient approach in rectal cancer. Radiother Oncol. 2011 Jul;100(1):15-21. doi: 10.1016/j.radonc.2011.05.024. Epub 2011 May 31.

Reference Type: BACKGROUND

PMID: 21632132 (View on PubMed)

Other Identifiers

ICM-BCB-2014/02

Identifier Type: -

Identifier Source: org_study_id