Clinical and Biological Database in Colon Cancer and Colic Tumors

Not Applicable

Recruiting

• Conditions: Cancer Colon
• Interventions: Other: Biological collection

• Registration Number: NCT03976960
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary

Developement of a clinical and biological database in colon cancer and colic tumors in order to better understand tumor invasion and metastatic scattering processes. The investigators hope that a better understanding of tumoral invasion process will lead to the discovery of new biomarkers and new drugs.

Detailed Description

As the second leading cause of cancer-related death in France, colorectal cancer is a major public health problem. Each year, 37 000 cases are newly diagnosed in France and 17 000 patients die of the disease.

Colorectal cancer is due to molecular and genetic damages involved in all tumorigenesis steps, transition from healthy tissue to adenoma and finally to invasive carcinoma stage. The investigators hope that a to better understand tumor invasion and metastatic scattering processes will allow therapeutic innovation and the emergence of new biomarkers.

However, the study of early tumorigenesis phases as well as advanced stages of the disease is currently limited due to a lack of tissue samples.

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

Study Timeline

• Study Start: 2018-09-19
• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-05
• Study First Posted: 2019-06-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Patient undergoing colon cancer surgery (stage I, II, III and IV)
2. Patient operated for liver or lung or peritoneal carcinomatosis metastases originating from colon cancer
3. Patient operated for pre-neoplastic lesion (adenomatous polyp /villous adenoma polyp),
4. Patient with familial polyposis eligible for colectomy
5. Age > 18 years
6. Signed informed consent

Exclusion Criteria

1. Patient not affiliated to Social Protection system
2. Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
3. Patient under guardianship
4. Minor patient

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 : samples of blood samples collected before or after surgery but also samples in paraffin-embedded tissue sections. In parallel to this biological collection, standardized clinical data will be entered into a database

Primary Outcome Measures

Name	Time	Method
Number of biological risk factors for colorectal cancer	Until the study completion : 6 years
Number of clinical risk factors for colorectal cancer	Until the study completion : 6 years

Trial Locations

Locations (2)

CHRU de Montpellier; 🇫🇷 Montpellier, Hérault, France

Institut Régional du cancer de Montpellier; 🇫🇷 Montpellier, France