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

Last updated: January 3, 2024
Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gall Bladder Cancer

Biliary Tract Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT04935853
ACABi PRONOBIL GB-115
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All locations of primitives (intrahepatic CCA, extrahepatic CCA, adenocarcinoma of thegallbladder; 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 therapeuticresearch protocol

Exclusion

Exclusion Criteria:

  • Patient under guardianship, curatorship or legal protection
  • Pregnant or breastfeeding women
  • Any medical, psychological or social situation, which could prevent the compliancewith the protocol according to the investigator's assessment
  • Refusal to participate in the study

Study Design

Total Participants: 1350
Study Start date:
May 23, 2022
Estimated Completion Date:
June 01, 2040

Study Description

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).

Connect with a study center

  • CHU Hôpital Sud Amiens

    Amiens,
    France

    Active - Recruiting

  • CHU Angers

    Angers,
    France

    Active - Recruiting

  • CHU Besançon

    Besançon,
    France

    Active - Recruiting

  • Hôpital Avicenne

    Bobigny,
    France

    Active - Recruiting

  • CHU - Henri Mondor

    Créteil,
    France

    Active - Recruiting

  • CHU Dijon

    Dijon,
    France

    Active - Recruiting

  • CHU Grenoble

    Grenoble,
    France

    Active - Recruiting

  • CHU Lille

    Lille,
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon,
    France

    Active - Recruiting

  • Hôpital Croix Rousse

    Lyon,
    France

    Active - Recruiting

  • Hôpital Edouard Herriot

    Lyon,
    France

    Active - Recruiting

  • Hôpital Privé Jean Mermoz

    Lyon,
    France

    Active - Recruiting

  • Institut Paoli Calmette

    Marseille,
    France

    Active - Recruiting

  • CHU Saint Eloi Montpellier

    Montpellier,
    France

    Active - Recruiting

  • CHU Nantes

    Nantes,
    France

    Active - Recruiting

  • Centre Antoine Lacassagne

    Nice,
    France

    Active - Recruiting

  • CHR Orléans

    Orléans,
    France

    Active - Recruiting

  • Groupe Hospitalier Pitié Salpêtrière

    Paris,
    France

    Active - Recruiting

  • Hôpital Ambroise Paré

    Paris,
    France

    Active - Recruiting

  • Hôpital Cochin

    Paris,
    France

    Active - Recruiting

  • Hôpital Saint Antoine

    Paris,
    France

    Active - Recruiting

  • Hôpital Saint Louis

    Paris,
    France

    Active - Recruiting

  • Institut Mutualiste Montsouris

    Paris,
    France

    Active - Recruiting

  • Hôpital Haut Lévêque

    Pessac,
    France

    Active - Recruiting

  • CHU Poitiers

    Potiers,
    France

    Active - Recruiting

  • Hôpital Robert Debré -CHU Reims

    Reims,
    France

    Active - Recruiting

  • Centre Eugène Marquis

    Rennes,
    France

    Active - Recruiting

  • CHU Rouen Charles Nicolle

    Rouen,
    France

    Active - Recruiting

  • Institut Curie

    Saint-Cloud,
    France

    Active - Recruiting

  • CHU Saint Etienne

    Saint-Étienne,
    France

    Active - Recruiting

  • CHU Rangueil

    Toulouse,
    France

    Active - Recruiting

  • CHU Tours

    Tours,
    France

    Active - Recruiting

  • CHRU Nancy Site Brabois

    Vandœuvre-lès-Nancy,
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif,
    France

    Active - Recruiting

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