RecruitingNCT05787197
ctDNA in CRC Patients Undergoing Curative-intent Surgery for Liver Metastases
Circulating Tumor DNA in Patients With Colorectal Cancer Undergoing Curative-intent Surgery for Liver Metastases: Prospective, Multicenter, GERCOR Cohort
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Enrollment
232 participants
Start Date
Jan 9, 2024
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria9
- 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).
Exclusion Criteria12
- 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.
Locations(16)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05787197
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