Clinical trial NCT05787197: ctDNA in CRC Patients Undergoing Curative-intent Surgery for Liver Metastases
Official title: Circulating Tumor DNA in Patients With Colorectal Cancer Undergoing Curative-intent Surgery for Liver Metastases: Prospective, Multicenter, GERCOR Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Colorectal Cancer
Circulating Tumor DNA
Lead sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Active file in oncology department

Brief 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.

Detailed description: Blood collection times according to specific clinical situations:

* Standard approach
* Combined surgery
* Reverse strategy
* Two-stage hepatectomy

Eligibility criteria: Inclusion criteria

The patient will be included if:

1. Has signed informed consent form and is willing to comply with all study procedures and availability for the study duration,
2. Is ≥ 18 years of age,
3. Has histologically confirmed colorectal adenocarcinoma,
4. 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,
5. 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 \[or MRI if CT not possible\]),
6. Is eligible to surgical procedure,
7. Is fit for the chemotherapy-surgery combination treatment,
8. Is registered in a national health care system (Protection Universelle Maladie \[PUMa\] included).

Exclusion criteria

The patient will be excluded if:

1. Has definitively unresectable CLRM,
2. Had more than 9 pre-operative cycles of chemotherapy for treatment of metastatic disease planned at inclusion,
3. Has not resected primary rectal tumor (low and middle),
4. 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,
5. Has no more than two surgical procedures planned for complete resection of primary tumor and/or liver metastases,
6. Has deficient mismatch repair (dMMR)/ microsatellite instability (MSI) tumors treated with immunotherapy,
7. Blood samples cannot be collected if surgical procedure,
8. Is pregnant or breastfeeding,
9. Cannot be followed-up due to geographical, social, or psychic conditions,
10. Has medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol,
11. Is under guardianship, curatorship, or under the protection of justice.

Primary outcomes:
measure: Disease-free survival (DFS) in patients who undergo curative-intent resection of colorectal liver metastasis (CRLM)
timeFrame: Up to 36 months
Secondary outcomes:
measure: Number of event-free survival (EFS) in patients who undergo curative-intent resection of CRLM.
timeFrame: Up to 4 years
measure: Overall survival (OS) n patients who undergo curative-intent resection of CRLM.
timeFrame: Up to 4 years
measure: Time to surgical failure (TSF) in patients who undergo curative-intent resection of CRLM.
timeFrame: Up to 4 years
measure: Prognostic value of ctDNA
timeFrame: Up to 4 years
measure: Prognostic factor(s) for disease recurrence and survival.
timeFrame: Up to 4 years
measure: Association between ctDNA and clinical features.
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonié
city: Lille
country: France
facility: CHU Lille - Hôpital Huriez
city: Lyon
country: France
facility: Centre Léon Bérard
city: Paris
country: France
facility: Hôpital Bichât Claude Bernard
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Pessac
country: France
facility: Hôpital Haut Lévêque
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rouen
country: France
facility: CHU Rouen
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Tours
country: France
facility: CHRU Tours
city: Villejuif
country: France
facility: Hôpital Paul Brousse
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Department of Digestive Surgery, Gustave Roussy Hospital
name: Maximiliano GELLI, MD
role: PRINCIPAL_INVESTIGATOR
References: