Prognostic and Predictive Markers of Response to Treatment in Patients With Bile Duct Cancer: ACABi PRONOBIL Study

NCT ID: NCT04935853

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-23

Study Completion Date

2040-06-01

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Biliary Tract Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* All locations of primitives (intrahepatic CCA, extrahepatic CCA, adenocarcinoma of the gallbladder; ampullomas excluded)
* Age \> 18 years
* Diagnosed between 2003 and 2030 (minimum follow-up 2 years)
* Written written non-opposition +/- signed informed consent for genetic studies (N.B.:

exemption requested for a deceased patient) N.B. Authorized inclusion in a therapeutic research protocol

Exclusion Criteria

* Patient under guardianship, curatorship or legal protection
* Pregnant or breastfeeding women
* Any medical, psychological or social situation, which could prevent the compliance with the protocol according to the investigator's assessment
* Refusal to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cindy Neuzillet, Dr

Role: PRINCIPAL_INVESTIGATOR

Institut Curie, Saint-Cloud

Locations

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CHU Hôpital Sud Amiens

Amiens, , France

Site Status RECRUITING

CHU Angers

Angers, , France

Site Status RECRUITING

CHU Besançon

Besançon, , France

Site Status RECRUITING

Hôpital Avicenne

Bobigny, , France

Site Status RECRUITING

CHU - Henri Mondor

Créteil, , France

Site Status RECRUITING

CHU Dijon

Dijon, , France

Site Status RECRUITING

CHU Grenoble

Grenoble, , France

Site Status RECRUITING

CHU Lille

Lille, , France

Site Status RECRUITING

Centre Léon Bérard

Lyon, , France

Site Status RECRUITING

Hôpital Croix Rousse

Lyon, , France

Site Status RECRUITING

Hôpital Edouard Herriot

Lyon, , France

Site Status RECRUITING

Hôpital Privé Jean Mermoz

Lyon, , France

Site Status RECRUITING

Institut Paoli Calmette

Marseille, , France

Site Status RECRUITING

CHU Saint Eloi Montpellier

Montpellier, , France

Site Status RECRUITING

CHR Orléans

Orléans, , France

Site Status RECRUITING

Groupe Hospitalier Pitié Salpêtrière

Paris, , France

Site Status RECRUITING

Hôpital Ambroise Paré

Paris, , France

Site Status RECRUITING

Hôpital Cochin

Paris, , France

Site Status RECRUITING

Hôpital Saint Antoine

Paris, , France

Site Status RECRUITING

Hôpital Saint Louis

Paris, , France

Site Status RECRUITING

Institut Mutualiste Montsouris

Paris, , France

Site Status RECRUITING

Hôpital Haut Lévêque

Pessac, , France

Site Status RECRUITING

CHU Poitiers

Potiers, , France

Site Status RECRUITING

Hôpital Robert Debré -CHU Reims

Reims, , France

Site Status RECRUITING

Centre Eugène Marquis

Rennes, , France

Site Status RECRUITING

CHU Rouen Charles Nicolle

Rouen, , France

Site Status RECRUITING

Institut Curie

Saint-Cloud, , France

Site Status RECRUITING

CHU Saint Etienne

Saint-Etienne, , France

Site Status RECRUITING

CHU Rangueil

Toulouse, , France

Site Status RECRUITING

CHU Tours

Tours, , France

Site Status RECRUITING

CHRU Nancy Site Brabois

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Institut Gustave Roussy

Villejuif, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cindy Neuzillet, Dr

Role: CONTACT

+33 (0)1 47 11 15 15

Marie-Line Garcia, Dr

Role: CONTACT

+33 (0)1 40 29 85 00

Facility Contacts

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Vincent HAUTEFEUILLE, MD

Role: primary

Carole VITELLIUS, MD

Role: primary

Angélique VIENOT, MD

Role: primary

Jean Charles NAULT, MD

Role: primary

Christophe TOURNIGAND, MD

Role: primary

Sylvain MANFREDI, MD

Role: primary

Gaël ROTH, MD

Role: primary

Anthony TURPIN, MD

Role: primary

Mathieu SARABI, MD

Role: primary

Marielle GUILLET, MD

Role: primary

Thomas WALTER, MD

Role: primary

Pascal ARTRU, MD

Role: primary

Brice CHANEZ, MD

Role: primary

Eric ASSENAT, MD

Role: primary

Jean Paul LAGASSE, MD

Role: primary

Jean Baptiste BACHET, MD

Role: primary

Aude GUILLEMIN, MD

Role: primary

Romain CORIAT, MD

Role: primary

Raphaël COLLE, MD

Role: primary

Nelson LOURENCO, MD

Role: primary

Christophe LOUVET, MD

Role: primary

Jean François BLANC, MD

Role: primary

David TOUGERON, MD

Role: primary

Alexandra HEURGUE, MD

Role: primary

Julien EDELINE, MD

Role: primary

Lilian SCHWARZ, MD

Role: primary

Cindy NEUZILLET, MD

Role: primary

Nicolas WILLET, MD

Role: primary

Nadim FARES, MD

Role: primary

Thierry LECOMTE, MD

Role: primary

Marie MULLER, MD

Role: primary

Antoine HOLLEBECQUE, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 39897613 (View on PubMed)

Other Identifiers

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ACABi PRONOBIL GB-115

Identifier Type: -

Identifier Source: org_study_id

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