Development of a Clinical and Biological Database in Rectum Cancer

Not Applicable

Recruiting

• Conditions: Rectal Neoplasms
• Interventions: Other: Biological collection

• Registration Number: NCT04006951
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

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.

Study Timeline

• Study Start: 2014-10-08
• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biological collection	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

Primary Outcome Measures

Name	Time	Method
Proportion of patients who gave their consent to participate in the study	Until the study completion : 66 months	The proportion of patients who consent to participate in the study among the screened patients

Trial Locations

Locations (1)

ICM Val d'Aurelle; 🇫🇷 Montpellier, France