CLIMES: Circulating Tumor DNA in Patients With Colorectal Cancer Undergoing Curative-intent Surgery for Liver Metastases: Prospective, Multicenter, GERCOR Cohort
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Blood collection times according to specific clinical situations:
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Standard approach
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Combined surgery
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Reverse strategy
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Two-stage hepatectomy
Study Design
Outcome Measures
Primary Outcome Measures
- Disease-free survival (DFS) in patients who undergo curative-intent resection of CRLM [Up to 36 months]
DFS is defined as the time from complete surgical resection (following first surgery if one-stage surgery or second surgery if two-stage strategy) to first documented event (relapse or death, whichever occurred first), or until last contact if no event occurs.
Secondary Outcome Measures
- Rate of ctDNA level at pre-operative chemotherapy timepoints in patients treated in including centers, [up to 36 months]
- Rate of pre-operative ctDNA positivity in patients with detectable ctDNA undergoing curative-intent resection of CRLM, [Up to 4 years]
- Number of Event-free survival (EFS) in patients who undergo curative-intent resection of CRLM, [Up to 4 years]
EFS is defined as time between inclusion until the occurrence of an event: disease progression, relapse, disease progression, or death from any reason.
- Overall survival (OS) [Up to 4 years]
OS is defined as the time between inclusion and death. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period.
- The time to surgical failure (TSF) [Up to 4 years]
The time to surgical failure (TSF) is defined as the time from initial surgery until the first unresectable recurrence or death from any cause or the date of the last follow-up, at which point data are censored
Eligibility Criteria
Criteria
Inclusion Criteria:
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Has signed informed consent form and is willing to comply with all study procedures and availability for the study duration,
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Is ≥ 18 years of age,
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Has histologically confirmed colorectal adenocarcinoma,
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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,
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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]),
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Is eligible to surgical procedure,
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Is fit for the chemotherapy-surgery combination treatment,
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Is registered in a national health care system (Protection Universelle Maladie [PUMa] included).
Exclusion Criteria:
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Has definitively unresectable CLRM,
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Had more than 9 pre-operative cycles of chemotherapy for treatment of metastatic disease planned at inclusion,
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Has not resected primary rectal tumor (low and middle),
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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,
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Has no more than two surgical procedures planned for complete resection of primary tumor and/or liver metastases,
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Has deficient mismatch repair (dMMR)/ microsatellite instability (MSI) tumors treated with immunotherapy,
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Blood samples cannot be collected if surgical procedure,
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Is pregnant or breastfeeding,
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Cannot be followed-up due to geographical, social, or psychic conditions,
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Has medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol,
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Is under guardianship, curatorship, or under the protection of justice.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Jean Minjoz | Besançon | France | ||
| 2 | Institut Bergonié | Bordeaux | France | ||
| 3 | CHU Lille - Hôpital Huriez | Lille | France | ||
| 4 | Centre Léon Bérard | Lyon | France | ||
| 5 | Hôpital Bichât Claude Bernard | Paris | France | ||
| 6 | Hôpital Cochin | Paris | France | ||
| 7 | Hôpital Pitié Salpêtrière | Paris | France | ||
| 8 | Hôpital Saint Antoine | Paris | France | ||
| 9 | Institut Mutualiste Montsouris | Paris | France | ||
| 10 | Hôpital Haut Lévêque | Pessac | France | ||
| 11 | CHU de Poitiers | Poitiers | France | ||
| 12 | CHU Rouen | Rouen | France | ||
| 13 | CHU Strasbourg | Strasbourg | France | ||
| 14 | CHRU Tours | Tours | France | ||
| 15 | Hôpital Paul Brousse | Villejuif | France | ||
| 16 | Institut Gustave Roussy | Villejuif | France |
Sponsors and Collaborators
- GERCOR - Multidisciplinary Oncology Cooperative Group
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLIMES G-118 CIRCULATE-4