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The objective of this study is to identify prognosis and predictive markers of response to treatments (surgery, chemotherapy, targeted therapy,loco-regional treatments ) in patients with bile duct cancer. The effectiveness and tolerance of these treatments in current practice will also be evaluated.
Bile duct cancers are a heterogeneous group of rare tumors with a poor prognosis. Surgery is the only curative modality for localized forms. Chemotherapy is the standard treatment in advanced forms. Identification of prognostic and predictive markers to better stratify patients and to guide therapeutic decisions is a major issue. It is retro-prospective (diagnosis between 2003 and 2021) and prospective (diagnosis between 2021 and 2030) multi-center, cohort study. Follow-up for 10 years from initial cancer diagnosis will be done.
Follow-up is retrospective only for patients operated on or diagnosed in the past for more than 10 years, and retro-prospective for operated patients or diagnosed in the past for less than 10 years.
The data collected for each patient are available during the life cycle of this clinical trial to fulfil an educational requirement (e.g. a doctoral thesis) upon request and authorization from the study committee and the study sponsor (GERCOR).
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with advanced bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months | Identification of clinical and tumor predictive factors of overall survival (OS) (prognostic markers) in patients with advanced bile duct cancer (BDC). OS defined as a period between the start of treatment and death, whatever the cause. | Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with localized bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months | Identification of clinical and tumor predictive factors of overall survival (OS) (prognostic markers) in patients with bile localized BDC (operated). OS defined as a period between the start of treatment and death, whatever the cause. | Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years) |
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Inclusion Criteria:
exemption requested for a deceased patient) N.B. Authorized inclusion in a therapeutic research protocol
Exclusion Criteria:
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Retro-prospective (diagnosis between 2003 and 2020) and prospective (diagnosis between 2021 and 2030) cohorts of patients with Bile Duct Cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cindy Neuzillet, Dr | Contact | +33 (0)1 47 11 15 15 | cindy.neuzillet@curie.fr | |
| Marie-Line Garcia, Dr | Contact | +33 (0)1 40 29 85 00 | marie-line.garcia-larnicol@gercor.com.fr |
| Name | Affiliation | Role |
|---|---|---|
| Cindy Neuzillet, Dr | Institut Curie, Saint-Cloud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Hôpital Sud Amiens | Recruiting | Amiens | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39897613 | Derived | Adamus N, Edeline J, Henriques J, Fares N, Lecomte T, Turpin A, Vernerey D, Vincens M, Chanez B, Tougeron D, Tournigand C, Assenat E, Delaye M, Manfredi S, Bouche O, Williet N, Vienot A, Blaise L, Mas L, Neuzillet C, Boileve A, Roth GS. First-line chemotherapy with selective internal radiation therapy for intrahepatic cholangiocarcinoma: The French ACABi GERCOR PRONOBIL cohort. JHEP Rep. 2024 Nov 20;7(2):101279. doi: 10.1016/j.jhepr.2024.101279. eCollection 2025 Feb. |
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| Response rate | Assessment of treatments effects on the response rate (RECIST v 1.1, Choi). | Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years) |
| Effect of treatments on secondary resection rate R0 of the primary tumor | Assessment of treatments on secondary resection rate R0 of the primary tumor | From day of surgical intervention until 30 days |
| Effects of treatments on disease-free survival (DFS) | Assessment of treatments effects on disease-free survival (DFS) in patients who underwent surgery. | Up to 10 years; The months between surgery and the first documented recurrence, second cancer, or death from any cause |
| Effects of treatments on progression-free survival (PFS) | Assessment of treatments effects on progression-free survival (PFS) in non-operated patients | Up to 10 years; The months between the start of treatment and the first progression or death, whatever be the cause |
| Toxicities (Adverse events) experienced by patients | Evaluation of toxicity assessed by CTCAE v 5.0 | Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years) |
| The complications and postoperative mortality rates in patients who underwent surgery | Assessment of the complications rate (Clavien classification) and of postoperative mortality in patients who underwent surgery | From day of surgical intervention until 30 days; up to 10 years |
| CHU Angers | Recruiting | Angers | France |
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| CHU Besançon | Recruiting | Besançon | France |
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| Hôpital Avicenne | Recruiting | Bobigny | France |
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| CHU - Henri Mondor | Recruiting | Créteil | France |
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| CHU Dijon | Recruiting | Dijon | France |
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| CHU Grenoble | Recruiting | Grenoble | France |
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| CHU Lille | Recruiting | Lille | France |
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| Centre Léon Bérard | Recruiting | Lyon | France |
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| Hôpital Croix Rousse | Recruiting | Lyon | France |
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| Hôpital Edouard Herriot | Recruiting | Lyon | France |
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| Hôpital Privé Jean Mermoz | Recruiting | Lyon | France |
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| Institut Paoli Calmette | Recruiting | Marseille | France |
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| CHU Saint Eloi Montpellier | Recruiting | Montpellier | France |
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| CHR Orléans | Recruiting | Orléans | France |
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| Groupe Hospitalier Pitié Salpêtrière | Recruiting | Paris | France |
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| Hôpital Ambroise Paré | Recruiting | Paris | France |
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| Hôpital Cochin | Recruiting | Paris | France |
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| Hôpital Saint Antoine | Recruiting | Paris | France |
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| Hôpital Saint Louis | 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 Poitiers | Recruiting | Potiers | France |
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| Hôpital Robert Debré -CHU Reims | Recruiting | Reims | France |
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| Centre Eugène Marquis | Recruiting | Rennes | France |
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| CHU Rouen Charles Nicolle | Recruiting | Rouen | France |
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| Institut Curie | Recruiting | Saint-Cloud | France |
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| CHU Saint Etienne | Recruiting | Saint-Etienne | France |
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| CHU Rangueil | Recruiting | Toulouse | France |
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| CHU Tours | Recruiting | Tours | France |
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| CHRU Nancy Site Brabois | Recruiting | Vandœuvre-lès-Nancy | France |
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| Institut Gustave Roussy | Recruiting | Villejuif | France |
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| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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