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

NCT05787197 | Recruiting DMC

• 1 other identifier: CLIMES G-118 CIRCULATE-4
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 16

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.

Conditions

Metastatic Colorectal Cancer; Circulating Tumor DNA

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS) in patients who undergo curative-intent resection of colorectal liver metastasis (CRLM)

  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.

  Up to 36 months

Secondary Outcomes (6)

• Number of event-free survival (EFS) in patients who undergo curative-intent resection of CRLM.

  Up to 4 years

• Overall survival (OS) n patients who undergo curative-intent resection of CRLM.

  Up to 4 years

• Time to surgical failure (TSF) in patients who undergo curative-intent resection of CRLM.

  Up to 4 years

• Prognostic value of ctDNA

  Up to 4 years

• Prognostic factor(s) for disease recurrence and survival.

  Up to 4 years

Eligibility Criteria

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

Study Population

Active file in oncology department

You may qualify if:

• The patient will be included if:
• Has signed informed consent form and is willing to comply with all study procedures and availability for the study duration,
• Is ≥ 18 years of age,
• Has histologically confirmed colorectal adenocarcinoma,
• Has isolated CRLM that is deemed resectable or potentially resectable (extrahepatic metastases excluded, except infracentimetric non-specific lung lesions with largest diameter \<1 cm and maximal number of ≤3) as judged by a multidisciplinary team meeting (based on CT scans of chest, abdomen, and pelvis \[or MRI if CT not possible\]),
• Is eligible to surgical procedure,
• Is fit for the chemotherapy-surgery combination treatment,
• Is registered in a national health care system (Protection Universelle Maladie \[PUMa\] included).

You may not qualify if:

• The patient will be excluded if:
• Has definitively unresectable CLRM,
• Has not resected primary rectal tumor (low and middle),
• Has history of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix,
• Has no more than two surgical procedures planned for complete resection of primary tumor and/or liver metastases,
• Has deficient mismatch repair (dMMR)/ microsatellite instability (MSI) tumors treated with immunotherapy,
• Blood samples cannot be collected if surgical procedure,
• Is pregnant or breastfeeding,
• Cannot be followed-up due to geographical, social, or psychic conditions,
• Has medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol,
• Is under guardianship, curatorship, or under the protection of justice.

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (16)

CHU Jean Minjoz

Besançon, France

NOT YET RECRUITING

Institut Bergonié

Bordeaux, France

RECRUITING

CHU Lille - Hôpital Huriez

Lille, France

RECRUITING

Centre Léon Bérard

Lyon, France

RECRUITING

Hôpital Bichât Claude Bernard

Paris, France

NOT YET RECRUITING

Hôpital Cochin

Paris, France

RECRUITING

Hôpital Pitié Salpêtrière

Paris, France

RECRUITING

Hôpital Saint Antoine

Paris, France

RECRUITING

Institut Mutualiste Montsouris

Paris, France

RECRUITING

Hôpital Haut Lévêque

Pessac, France

RECRUITING

CHU de Poitiers

Poitiers, France

RECRUITING

CHU Rouen

Rouen, France

NOT YET RECRUITING

CHU Strasbourg

Strasbourg, France

RECRUITING

CHRU Tours

Tours, France

RECRUITING

Hôpital Paul Brousse

Villejuif, France

RECRUITING

Institut Gustave Roussy

Villejuif, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples collected in the pre-operative setting.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Maximiliano GELLI, MD

  Department of Digestive Surgery, Gustave Roussy Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maximiliano GELLI, MD

CONTACT

+33(0)1 40 29 85 00; maximiliano.gelli@gustaveroussy.fr

Marie Line GARCIA, MD

CONTACT

+33(0)1 40 29 85 00; marie-line.garcia-larnicol@gercor.com.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 28, 2023
• Study Start: January 9, 2024
• Primary Completion: September 25, 2025
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

FR (16)