ctDNA in CRC Patients Undergoing Curative-intent Surgery for Liver Metastases
Recruiting now
Conditions studied: Metastatic Colorectal Cancer, Circulating Tumor DNA
In brief
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.
Key facts
- Study ID
- NCT05787197
- Run by
- GERCOR - Multidisciplinary Oncology Cooperative Group
- People needed
- 232
- Starts
- 2024-01-09
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2025-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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 resected primary tumor or is eligible to primary tumor and CRLM (in case of synchronous metastases) resection within 6 months prior to study inclusion,
- 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,
- Had more than 9 pre-operative cycles of chemotherapy for treatment of metastatic disease planned at inclusion,
- 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.
Where it is running
- Institut Gustave Roussy — Villejuif, France (enrolling)
- Institut Bergonié — Bordeaux, France (enrolling)
- CHU Lille - Hôpital Huriez — Lille, France (enrolling)
- Centre Léon Bérard — Lyon, France (enrolling)
- CHU Strasbourg — Strasbourg, France (enrolling)
- CHRU Tours — Tours, France (enrolling)
- Hôpital Paul Brousse — Villejuif, France (enrolling)
- Hôpital Cochin — Paris, France (enrolling)
- Hôpital Pitié Salpêtrière — Paris, France (enrolling)
- Hôpital Saint Antoine — Paris, France (enrolling)
- Institut Mutualiste Montsouris — Paris, France (enrolling)
- Hôpital Haut Lévêque — Pessac, France (enrolling)
- CHU de Poitiers — Poitiers, France (enrolling)
- Hôpital Bichât Claude Bernard — Paris, France
- CHU Rouen — Rouen, France
- CHU Jean Minjoz — Besançon, France
Full record on ClinicalTrials.gov
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