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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.
Blood collection times according to specific clinical situations:
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| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) in patients who undergo curative-intent resection of colorectal liver metastasis (CRLM) | 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. | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of event-free survival (EFS) in patients who undergo curative-intent resection of CRLM. | EFS is defined as time between inclusion until the occurrence of an event: disease progression, relapse, disease progression, or death from any reason. | Up to 4 years |
| Overall survival (OS) n patients who undergo curative-intent resection of CRLM. |
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Inclusion criteria
The patient will be included if:
Exclusion criteria
The patient will be excluded if:
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Active file in oncology department
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maximiliano GELLI, MD | Contact | +33(0)1 40 29 85 00 | maximiliano.gelli@gustaveroussy.fr | |
| Marie Line GARCIA, MD | Contact | +33(0)1 40 29 85 00 | marie-line.garcia-larnicol@gercor.com.fr |
| Name | Affiliation | Role |
|---|---|---|
| Maximiliano GELLI, MD | Department of Digestive Surgery, Gustave Roussy Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Jean Minjoz | Not yet recruiting | Besançon | France |
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Blood samples collected in the pre-operative setting.
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. |
| Up to 4 years |
| Time to surgical failure (TSF) in patients who undergo curative-intent resection of CRLM. | TFS 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. | Up to 4 years |
| Prognostic value of ctDNA | Prognostic value of ctDNA:
| Up to 4 years |
| Prognostic factor(s) for disease recurrence and survival. | Prognostic factor(s) for disease recurrence and survival in patients who undergo curative-intent resection of CRLM. | Up to 4 years |
| Association between ctDNA and clinical features. | To identify the clinical, biological, and pathological factors associated with the ctDNA level. | Up to 4 years |
| Institut Bergonié | Recruiting | Bordeaux | France |
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| CHU Lille - Hôpital Huriez | Recruiting | Lille | France |
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| Centre Léon Bérard | Recruiting | Lyon | France |
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| Hôpital Bichât Claude Bernard | Not yet recruiting | Paris | France |
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| Hôpital Cochin | Recruiting | Paris | France |
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| Hôpital Pitié Salpêtrière | Recruiting | Paris | France |
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| Hôpital Saint Antoine | Recruiting | Paris | France |
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| Institut Mutualiste Montsouris | Recruiting | Paris | France |
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| Hôpital Haut Lévêque | Recruiting | Pessac | France |
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| CHU de Poitiers | Recruiting | Poitiers | France |
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| CHU Rouen | Not yet recruiting | Rouen | France |
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| CHU Strasbourg | Recruiting | Strasbourg | France |
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| CHRU Tours | Recruiting | Tours | France |
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| Hôpital Paul Brousse | Recruiting | Villejuif | France |
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| Institut Gustave Roussy | Recruiting | Villejuif | France |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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