Development of a Clinical and Biological Database in Rectum Cancer

NCT04006951 | Recruiting

• 1 other identifier: ICM-BCB-2014/02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Neoplasms

Keywords

Cancer; Colorectal cancer; Biological Specimen Banks

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who gave their consent to participate in the study

  The proportion of patients who consent to participate in the study among the screened patients

  Until the study completion : 66 months

Study Arms (1)

Biological collection

EXPERIMENTAL

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

Interventions

Biological collection OTHER

Blood samples are collected at different times : * Before any treatment * After pre-operative radiochemotherapy and before surgery (if applicable)

Biological collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

ICM Val d'Aurelle

Montpellier, 34298, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 21632132 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms; Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases

Study Officials

• ROUANET Philippe, MD-PhD

  Institut régional du Cancer Montpellier

  STUDY CHAIR

Central Study Contacts

Aurore MOUSSION

CONTACT

4 67 61 31 02; drci-icm105@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: October 8, 2014
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)