ctDNA in CRC Patients Undergoing Curative-intent Surgery for Liver Metastases

Recruiting

• Conditions: Metastatic Colorectal Cancer; Circulating Tumor DNA

• Registration Number: NCT05787197
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary

This is a prospective multicenter cohort study, was designed to explore the prognostic value of ctDNA as a biomarker of disease response and recurrence or death in patients undergoing curative-intent surgical resection of Colorectal cancer liver metastasis.

Detailed Description

Blood collection times according to specific clinical situations:

* Standard approach

* Combined surgery

* Reverse strategy

* Two-stage hepatectomy

Study Timeline

• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-24
• Study First Posted: 2023-03-28
• Status Verified: 2024-01
• Study Start: 2024-01-09
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05
• Primary Completion: 2025-09-25
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS) in patients who undergo curative-intent resection of colorectal liver metastasis (CRLM)	Up to 36 months	DFS is defined as the time from complete surgical resection (following first surgery if one-stage surgery or second surgery if two-stage strategy) to first documented event (relapse or death, whichever occurred first), or until last contact if no event occurs.

Secondary Outcome Measures

Name	Time	Method
Prognostic factor(s) for disease recurrence and survival.	Up to 4 years	Prognostic factor(s) for disease recurrence and survival in patients who undergo curative-intent resection of CRLM.
Number of event-free survival (EFS) in patients who undergo curative-intent resection of CRLM.	Up to 4 years	EFS is defined as time between inclusion until the occurrence of an event: disease progression, relapse, disease progression, or death from any reason.
Overall survival (OS) n patients who undergo curative-intent resection of CRLM.	Up to 4 years	OS is defined as the time between inclusion and death. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period.
Time to surgical failure (TSF) in patients who undergo curative-intent resection of CRLM.	Up to 4 years	TFS is defined as the time from initial surgery until the first unresectable recurrence or death from any cause or the date of the last follow-up, at which point data are censored.
Prognostic value of ctDNA	Up to 4 years	Prognostic value of ctDNA: * post-operative ctDNA detection,; * relative change in ctDNA level after curative resection of CRLM,; * ctDNA in different subgroups of patients classified according to the type of surgical strategy (standard approach, combined surgery, reverse strategy, two-staged hepatectomy),
Association between ctDNA and clinical features.	Up to 4 years	To identify the clinical, biological, and pathological factors associated with the ctDNA level.

Trial Locations

Locations (16)

CHU de Poitiers; 🇫🇷 Poitiers, France

CHU Rouen; 🇫🇷 Rouen, France

Hôpital Pitié Salpêtrière; 🇫🇷 Paris, France

CHU Jean Minjoz; 🇫🇷 Besançon, France

CHU Strasbourg; 🇫🇷 Strasbourg, France

CHRU Tours; 🇫🇷 Tours, France

Hôpital Paul Brousse; 🇫🇷 Villejuif, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Hôpital Cochin; 🇫🇷 Paris, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Hôpital Haut Lévêque; 🇫🇷 Pessac, France

CHU Lille - Hôpital Huriez; 🇫🇷 Lille, France

Hôpital Saint Antoine; 🇫🇷 Paris, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Hôpital Bichât Claude Bernard; 🇫🇷 Paris, France