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

January 3, 2024 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

Marqueurs Pronostiques et prédictifs de réponse Aux Traitements Chez Les Patients Atteints de Cancer Des Voies Biliaires : Cohorte Multicentrique ACABi PRONOBIL

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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).

Study Type

Observational

Enrollment (Estimated)

1350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France
        • Recruiting
        • CHU Hôpital Sud Amiens
        • Contact:
          • Vincent HAUTEFEUILLE, MD
      • Angers, France
        • Recruiting
        • CHU Angers
        • Contact:
          • Carole VITELLIUS, MD
      • Besançon, France
        • Recruiting
        • CHU Besançon
        • Contact:
          • Angélique VIENOT, MD
      • Bobigny, France
        • Recruiting
        • Hôpital Avicenne
        • Contact:
          • Jean Charles NAULT, MD
      • Créteil, France
        • Recruiting
        • CHU - Henri Mondor
        • Contact:
          • Christophe TOURNIGAND, MD
      • Dijon, France
        • Recruiting
        • CHU Dijon
        • Contact:
          • Sylvain MANFREDI, MD
      • Grenoble, France
        • Recruiting
        • CHU Grenoble
        • Contact:
          • Gael ROTH, MD
      • Lille, France
        • Recruiting
        • CHU Lille
        • Contact:
          • Anthony TURPIN, MD
      • Lyon, France
        • Recruiting
        • Centre Leon Berard
        • Contact:
          • Mathieu SARABI, MD
      • Lyon, France
        • Recruiting
        • Hopital Privé Jean Mermoz
        • Contact:
          • Pascal ARTRU, MD
      • Lyon, France
        • Recruiting
        • Hôpital Edouard Herriot
        • Contact:
          • Thomas WALTER, MD
      • Lyon, France
        • Recruiting
        • Hopital Croix Rousse
        • Contact:
          • Marielle GUILLET, MD
      • Marseille, France
        • Recruiting
        • Institut Paoli Calmette
        • Contact:
          • Brice CHANEZ, MD
      • Montpellier, France
        • Recruiting
        • CHU Saint Eloi Montpellier
        • Contact:
          • Eric ASSENAT, MD
      • Nantes, France
        • Recruiting
        • CHU Nantes
        • Contact:
          • Yann TOUCHEFEU, MD
      • Nice, France
        • Recruiting
        • Centre Antoine Lacassagne
        • Contact:
          • Ludovic EVESQUE, MD
      • Orléans, France
        • Recruiting
        • CHR Orleans
        • Contact:
          • Jean Paul LAGASSE, MD
      • Paris, France
        • Recruiting
        • Hôpital Cochin
        • Contact:
          • Romain CORIAT, MD
      • Paris, France
        • Recruiting
        • Hopital Saint Louis
        • Contact:
          • Nelson LOURENCO, MD
      • Paris, France
        • Recruiting
        • Hopital Saint Antoine
        • Contact:
          • Raphaël COLLE, MD
      • Paris, France
        • Recruiting
        • Institut Mutualiste Montsouris
        • Contact:
          • Christophe LOUVET, MD
      • Paris, France
        • Recruiting
        • Groupe Hospitalier Pitie Salpetriere
        • Contact:
          • Jean Baptiste BACHET, MD
      • Paris, France
        • Recruiting
        • Hopital Ambroise Pare
        • Contact:
          • Aude GUILLEMIN, MD
      • Pessac, France
        • Recruiting
        • Hôpital Haut Lévêque
        • Contact:
          • Jean François BLANC, MD
      • Potiers, France
        • Recruiting
        • CHU Poitiers
        • Contact:
          • David TOUGERON, MD
      • Reims, France
        • Recruiting
        • Hôpital Robert Debré -CHU Reims
        • Contact:
          • Alexandra HEURGUE, MD
      • Rennes, France
        • Recruiting
        • Centre Eugene Marquis
        • Contact:
          • Julien EDELINE, MD
      • Rouen, France
        • Recruiting
        • CHU Rouen Charles Nicolle
        • Contact:
          • Lilian SCHWARZ, MD
      • Saint-Cloud, France
        • Recruiting
        • Institut Curie
        • Contact:
          • Cindy NEUZILLET, MD
      • Saint-Étienne, France
        • Recruiting
        • CHU Saint Etienne
        • Contact:
          • Nicolas WILLET, MD
      • Toulouse, France
        • Recruiting
        • CHU Rangueil
        • Contact:
          • Nadim FARES, MD
      • Tours, France
        • Recruiting
        • Chu Tours
        • Contact:
          • Thierry LECOMTE, MD
      • Vandœuvre-lès-Nancy, France
        • Recruiting
        • CHRU Nancy Site Brabois
        • Contact:
          • Marie MULLER, MD
      • Villejuif, France
        • Recruiting
        • Institut Gustave Roussy
        • Contact:
          • Antoine HOLLEBECQUE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Retro-prospective (diagnosis between 2003 and 2020) and prospective (diagnosis between 2021 and 2030) cohorts of patients with Bile Duct Cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients with advanced bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months
Time Frame: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)

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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients with localized bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months
Time Frame: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)

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)
Response rate
Time Frame: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)
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
Time Frame: From day of surgical intervention until 30 days
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)
Time Frame: Up to 10 years; The months between surgery and the first documented recurrence, second cancer, or death from any cause
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)
Time Frame: Up to 10 years; The months between the start of treatment and the first progression or death, whatever be the cause
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
Time Frame: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)
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
Time Frame: From day of surgical intervention until 30 days; up to 10 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

  • Principal Investigator: Cindy Neuzillet, Dr, Institut Curie, Saint-Cloud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2022

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2040

Study Registration Dates

First Submitted

May 28, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACABi PRONOBIL GB-115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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