Actively Recruiting
Circulating Tumor DNA in Patients With Colorectal Cancer Undergoing Curative-intent Surgery for Liver Metastases: Prospective Multicenter GERCOR Cohort
Led by GERCOR - Multidisciplinary Oncology Cooperative Group · Updated on 2025-07-23
232
Participants Needed
16
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the prognostic value of circulating tumor DNA (ctDNA) as a biomarker to predict disease response, recurrence, or death in patients undergoing surgery to remove colorectal cancer liver metastases. This prospective multicenter cohort study focuses on patients with colorectal adenocarcinoma who are eligible for curative-intent liver surgery. The goal is to better understand how ctDNA levels relate to patient outcomes after surgery. Participants will have blood collected at specific times based on their clinical situation, including standard surgery, combined surgery, reverse strategy, or two-stage hepatectomy approaches. The study observes patients undergoing curative surgical resection of isolated colorectal liver metastases considered resectable or potentially resectable by a multidisciplinary team. No experimental drugs or treatments are administered as this is an observational study. During the study, researchers will monitor disease-free survival up to 36 months after surgery and collect data on event-free survival, overall survival, time to surgical failure, and the prognostic value of ctDNA for up to 4 years. Assessments include clinical evaluations and blood sample collections to correlate ctDNA with outcomes and clinical features. Participants will be followed regularly to track these measures, with the total study duration lasting several years to observe long-term outcomes.
CONDITIONS
Brief Title
ctDNA in CRC Patients Undergoing Curative-intent Surgery for Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willingness to comply with study procedures
- Age 18 years or older
- Histologically confirmed colorectal adenocarcinoma
- Resected primary tumor or eligible for primary tumor and liver metastasis surgery within 6 months prior to inclusion
- Isolated colorectal liver metastases deemed resectable or potentially resectable by multidisciplinary team (excluding most extrahepatic metastases)
- Eligible for surgical procedure
- Fit for chemotherapy and surgery combination
- Registered in a national health care system including Protection Universelle Maladie (PUMa)
You will not qualify if you...
- Definitively unresectable colorectal liver metastases
- More than 9 pre-operative chemotherapy cycles planned for metastatic disease
- Primary rectal tumor not resected (low and middle)
- History of another primary cancer within last 5 years except certain skin or cervical cancers
- More than two surgical procedures planned for complete tumor and/or liver metastases resection
- Deficient mismatch repair or microsatellite instability tumors treated with immunotherapy
- Inability to collect blood samples at surgery
- Pregnant or breastfeeding
- Unable to follow-up due to geographical, social, or psychiatric conditions
- Medical, psychiatric, or occupational conditions preventing protocol compliance
- Under guardianship, curatorship, or legal protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants undergo curative-intent surgery for colorectal liver metastases with blood collections according to specific clinical situations.
1 surgery visit and blood collection at surgery
Duration - Up to 4 years
Participants are monitored for disease-free survival, event-free survival, overall survival, and prognostic factors for up to 4 years following surgery.
Follow-up visits according to clinical practice
Trial Site Locations
Total: 16 locations
1
CHU Jean Minjoz
Besançon, France
Not Yet Recruiting
2
Institut Bergonié
Bordeaux, France
Actively Recruiting
3
CHU Lille - Hôpital Huriez
Lille, France
Actively Recruiting
4
Centre Léon Bérard
Lyon, France
Actively Recruiting
5
Hôpital Bichât Claude Bernard
Paris, France
Not Yet Recruiting
6
Hôpital Cochin
Paris, France
Actively Recruiting
7
Hôpital Pitié Salpêtrière
Paris, France
Actively Recruiting
8
Hôpital Saint Antoine
Paris, France
Actively Recruiting
9
Institut Mutualiste Montsouris
Paris, France
Actively Recruiting
10
Hôpital Haut Lévêque
Pessac, France
Actively Recruiting
11
CHU de Poitiers
Poitiers, France
Actively Recruiting
12
CHU Rouen
Rouen, France
Not Yet Recruiting
13
CHU Strasbourg
Strasbourg, France
Actively Recruiting
14
CHRU Tours
Tours, France
Actively Recruiting
15
Hôpital Paul Brousse
Villejuif, France
Actively Recruiting
16
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
M
Maximiliano GELLI, MD
M
Marie Line GARCIA, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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