Development of Clinical and Biological Database in Colorectal Cancer

NCT04186117 | Completed

• 1 other identifier: URC 2015/16
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

Creation of circulating cancer cell-lines and caracterisation of these cell-lines which will be collected before any treatment in patients with metastatic colon adenocarcinoma

Conditions

Metastatic Colon Cancer

Keywords

colon cancer; circulating tumoral cells

Outcome Measures

Primary Outcomes (1)

• Isolation of circulating tumoral cells

  among 100 patients, to isolate at least 10 cell-lines to show the heterogeneity between patients

  Until the study completion : 54 months

Study Arms (1)

Biological collection

EXPERIMENTAL

For all the patients include in the study : \- Blood samples collected at before any treatment In parallel to this biological collection, standardized clinical data will be entered into a database

Other: Blood sample

Interventions

Blood sample OTHER

Blood sample before any treatment

Biological collection

Eligibility Criteria

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

You may qualify if:

• Male or female ≥ 18 years
• Histological evidence of metastatic colorectal cancer
• Naïve patients receiving chemotherapy at the metastatic stage or who have received adjuvant chemotherapy for more than 6 months
• Obtain signed informed consent prior to any specific preselection procedure.

You may not qualify if:

• History of Chemotherapy Treatment and / or Targeted Therapy for Metastatic Colorectal Cancer
• Breastfeeding or pregnant woman
• Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons
• Any severe or unstable medical, psychiatric or other condition that may interfere with the patient's safety, consent or compliance with the study protocol
• Patient not benefiting from a social security scheme

Sponsors & Collaborators

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

Study Sites (1)

ICM Val d'Aurelle

Montpellier, 34298, France

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Emmanuelle SAMALIN, MD

  Institut Régional du Cancer de Montpellier (ICM)

  STUDY CHAIR

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: December 2, 2019
• First Posted: December 4, 2019
• Study Start: September 9, 2016
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

FR (1)