Overview
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.
Description
Blood collection times according to specific clinical situations:
- Standard approach
- Combined surgery
- Reverse strategy
- Two-stage hepatectomy
Eligibility
Inclusion criteria
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 criteria
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.