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

Recruiting

• Conditions: Biliary Tract Cancer

• Registration Number: NCT04935853
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

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.

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 Timeline

• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-23
• Study Start: 2022-05-23
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05
• Primary Completion: 2030-06-01
• Study Completion: 2040-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1350

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of patients with advanced 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)	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.

Secondary Outcome Measures

Name	Time	Method
Toxicities (Adverse events) experienced by patients	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
Response rate	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).
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	Assessment of treatments effects on disease-free survival (DFS) in patients who underwent surgery.
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	Assessment of treatments effects on progression-free survival (PFS) in non-operated patients
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)	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.
Effect of treatments on secondary resection rate R0 of the primary tumor	From day of surgical intervention until 30 days	Assessment of treatments on secondary resection rate R0 of the primary tumor
The complications and postoperative mortality rates in patients who underwent surgery	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

Trial Locations

Locations (34)

CHU Hôpital Sud Amiens; 🇫🇷 Amiens, France

CHU Angers; 🇫🇷 Angers, France

Hôpital Avicenne; 🇫🇷 Bobigny, France

Hôpital Privé Jean Mermoz; 🇫🇷 Lyon, France

CHR Orléans; 🇫🇷 Orléans, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

CHU Poitiers; 🇫🇷 Potiers, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Hôpital Croix Rousse; 🇫🇷 Lyon, France

CHU Besançon; 🇫🇷 Besançon, France

CHU - Henri Mondor; 🇫🇷 Créteil, France

CHU Dijon; 🇫🇷 Dijon, France

CHU Grenoble; 🇫🇷 Grenoble, France

CHU Lille; 🇫🇷 Lille, France

Institut Paoli Calmette; 🇫🇷 Marseille, France

CHU Saint Eloi Montpellier; 🇫🇷 Montpellier, France

CHU Nantes; 🇫🇷 Nantes, France

Hôpital Ambroise Paré; 🇫🇷 Paris, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

Institut Curie; 🇫🇷 Saint-Cloud, France

CHRU Nancy Site Brabois; 🇫🇷 Vandœuvre-lès-Nancy, France

Groupe Hospitalier Pitié Salpêtrière; 🇫🇷 Paris, France

Hôpital Saint Antoine; 🇫🇷 Paris, France

CHU Rangueil; 🇫🇷 Toulouse, France

Hôpital Haut Lévêque; 🇫🇷 Pessac, France

Hôpital Robert Debré -CHU Reims; 🇫🇷 Reims, France

CHU Rouen Charles Nicolle; 🇫🇷 Rouen, France

CHU Saint Etienne; 🇫🇷 Saint-Étienne, France

CHU Tours; 🇫🇷 Tours, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Hôpital Cochin; 🇫🇷 Paris, France

Hôpital Saint Louis; 🇫🇷 Paris, France