Trial Title:
ctDNA in CRC Patients Undergoing Curative-intent Surgery for Liver Metastases
NCT ID:
NCT05787197
Condition:
Metastatic Colorectal Cancer
Circulating Tumor DNA
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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
Criteria for eligibility:
Study pop:
Active file in oncology department
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Jean Minjoz
Address:
City:
Besançon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Christophe BORG, MD
Facility:
Name:
Institut Bergonié
Address:
City:
Bordeaux
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Grégoire DESOLNEUX, MD
Facility:
Name:
CHU Lille - Hôpital Huriez
Address:
City:
Lille
Country:
France
Status:
Recruiting
Contact:
Last name:
Stéphanie TRUANT, MD
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Aurélien DUPRE, MD
Facility:
Name:
Hôpital Bichât Claude Bernard
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Gaël GOUJON, MD
Facility:
Name:
Hôpital Cochin
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
David FUKS, MD
Facility:
Name:
Hôpital Pitié Salpêtrière
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Claire GOUMARD, MD
Facility:
Name:
Hôpital Saint Antoine
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
François PAYE, MD
Facility:
Name:
Institut Mutualiste Montsouris
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
David MLAKA, MD
Facility:
Name:
Hôpital Haut Lévêque
Address:
City:
Pessac
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Denis SMITH, MD
Facility:
Name:
CHU de Poitiers
Address:
City:
Poitiers
Country:
France
Status:
Recruiting
Contact:
Last name:
Camille EVRARD, MD
Facility:
Name:
CHU Rouen
Address:
City:
Rouen
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Frédéric FIORE, MD
Facility:
Name:
CHU Strasbourg
Address:
City:
Strasbourg
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Pietro ADDEO, MD
Facility:
Name:
CHRU Tours
Address:
City:
Tours
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Petru BUCUR, MD
Facility:
Name:
Hôpital Paul Brousse
Address:
City:
Villejuif
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
René ADAM, MD
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Maximiliano GELLI, MD
Start date:
January 9, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
GERCOR - Multidisciplinary Oncology Cooperative Group
Agency class:
Other
Source:
GERCOR - Multidisciplinary Oncology Cooperative Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05787197
