Prognostic and Predictive Markers of Response to Treatment in Patients With Bile Duct Cancer: ACABi PRONOBIL Study
Marqueurs Pronostiques et prédictifs de réponse Aux Traitements Chez Les Patients Atteints de Cancer Des Voies Biliaires : Cohorte Multicentrique ACABi PRONOBIL
1 other identifier
observational
1,350
1 country
32
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Longer than P75 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2021
CompletedFirst Posted
Study publicly available on registry
June 23, 2021
CompletedStudy Start
First participant enrolled
May 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2040
July 23, 2025
July 1, 2025
8 years
May 28, 2021
July 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (7)
Rate of patients with localized bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months
Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)
Response rate
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
From day of surgical intervention until 30 days
Effects of treatments on disease-free survival (DFS)
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)
Up to 10 years; The months between the start of treatment and the first progression or death, whatever be the cause
- +2 more secondary outcomes
Eligibility Criteria
Retro-prospective (diagnosis between 2003 and 2020) and prospective (diagnosis between 2021 and 2030) cohorts of patients with Bile Duct Cancer
You may qualify if:
- 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.:
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
CHU Hôpital Sud Amiens
Amiens, France
CHU Angers
Angers, France
CHU Besançon
Besançon, France
Hôpital Avicenne
Bobigny, France
CHU - Henri Mondor
Créteil, France
CHU Dijon
Dijon, France
CHU Grenoble
Grenoble, France
CHU Lille
Lille, France
Centre Léon Bérard
Lyon, France
Hôpital Croix Rousse
Lyon, France
Hôpital Edouard Herriot
Lyon, France
Hôpital Privé Jean Mermoz
Lyon, France
Institut Paoli Calmette
Marseille, France
CHU Saint Eloi Montpellier
Montpellier, France
CHR Orléans
Orléans, France
Groupe Hospitalier Pitié Salpêtrière
Paris, France
Hôpital Ambroise Paré
Paris, France
Hôpital Cochin
Paris, France
Hôpital Saint Antoine
Paris, France
Hôpital Saint Louis
Paris, France
Institut Mutualiste Montsouris
Paris, France
Hôpital Haut Lévêque
Pessac, France
CHU Poitiers
Potiers, France
Hôpital Robert Debré -CHU Reims
Reims, France
Centre Eugène Marquis
Rennes, France
CHU Rouen Charles Nicolle
Rouen, France
Institut Curie
Saint-Cloud, France
CHU Saint Etienne
Saint-Etienne, France
CHU Rangueil
Toulouse, France
CHU Tours
Tours, France
CHRU Nancy Site Brabois
Vandœuvre-lès-Nancy, France
Institut Gustave Roussy
Villejuif, France
Related Publications (1)
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.
PMID: 39897613DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cindy Neuzillet, Dr
Institut Curie, Saint-Cloud
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2021
First Posted
June 23, 2021
Study Start
May 23, 2022
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 1, 2040
Last Updated
July 23, 2025
Record last verified: 2025-07