RECRUITINGOBSERVATIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Inclusion criteria
The patient will be included if:
1. Has signed willing to sign a consent form form and is willing to comply with all study procedures and availability for the study duration,
2. Is ≥ 18 years of age,
3. Has diagnosed by tissue sample (biopsy-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,
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Locations (16)
CHU Jean Minjoz
Besançon, France
Institut Bergonié
Bordeaux, France
CHU Lille - Hôpital Huriez
Lille, France
Centre Léon Bérard
Lyon, France
Hôpital Bichât Claude Bernard
Paris, France
Hôpital Cochin
Paris, France
Hôpital Pitié Salpêtrière
Paris, France
Hôpital Saint Antoine
Paris, France
Institut Mutualiste Montsouris
Paris, France
Hôpital Haut Lévêque
Pessac, France
CHU de Poitiers
Poitiers, France
CHU Rouen
Rouen, France
CHU Strasbourg
Strasbourg, France
CHRU Tours
Tours, France
Hôpital Paul Brousse
Villejuif, France
Institut Gustave Roussy
Villejuif, France