ctDNA in CRC Patients Undergoing Curative-intent Surgery for Liver Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Metastatic Colorectal Cancer, Circulating Tumor DNA. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Circulating Tumor DNA in Patients With Colorectal Cancer Undergoing Curative-intent Surgery for Liver Metastases: Prospective, Multicenter, GERCOR Cohort
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.
Detailed description
Blood collection times according to specific clinical situations:
* Standard approach * Combined surgery * Reverse strategy * Two-stage hepatectomy
Primary outcome measures
- Disease-free survival (DFS) in patients who undergo curative-intent resection of colorectal liver metastasis (CRLM) [Time frame: Up to 36 months]
Secondary outcome measures (6)
- Number of event-free survival (EFS) in patients who undergo curative-intent resection of CRLM. [Time frame: Up to 4 years]
- Overall survival (OS) n patients who undergo curative-intent resection of CRLM. [Time frame: Up to 4 years]
- Time to surgical failure (TSF) in patients who undergo curative-intent resection of CRLM. [Time frame: Up to 4 years]
- Prognostic value of ctDNA [Time frame: Up to 4 years]
- Prognostic factor(s) for disease recurrence and survival. [Time frame: Up to 4 years]
- Association between ctDNA and clinical features. [Time frame: Up to 4 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 16 centers
- CHU Jean Minjoz — Besançon
- Institut Bergonié — Bordeaux
- CHU Lille - Hôpital Huriez — Lille
- Centre Léon Bérard — Lyon
- Hôpital Bichât Claude Bernard — Paris
- Hôpital Cochin — Paris
- Hôpital Pitié Salpêtrière — Paris
- Hôpital Saint Antoine — Paris
- … and 8 more centers
Identifiers
NCT: NCT05787197 · CLIMES G-118 CIRCULATE-4