Clinical trial NCT04935853: Prognostic and Predictive Markers of Response to Treatment in Patients With Bile Duct Cancer: ACABi PRONOBIL Study
Official title: Marqueurs Pronostiques et prédictifs de réponse Aux Traitements Chez Les Patients Atteints de Cancer Des Voies Biliaires : Cohorte Multicentrique ACABi PRONOBIL
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Biliary Tract Cancer
Keywords: predictive
prognostic
biliary track cancer
Lead sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 1350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Rate of patients with advanced bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months
timeFrame: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)
Secondary outcomes:
measure: Rate of patients with localized bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months
timeFrame: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)
measure: Response rate
timeFrame: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)
measure: Effect of treatments on secondary resection rate R0 of the primary tumor
timeFrame: From day of surgical intervention until 30 days
measure: Effects of treatments on disease-free survival (DFS)
timeFrame: Up to 10 years; The months between surgery and the first documented recurrence, second cancer, or death from any cause
measure: Effects of treatments on progression-free survival (PFS)
timeFrame: Up to 10 years; The months between the start of treatment and the first progression or death, whatever be the cause
measure: Toxicities (Adverse events) experienced by patients
timeFrame: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)
measure: The complications and postoperative mortality rates in patients who underwent surgery
timeFrame: From day of surgical intervention until 30 days; up to 10 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Hôpital Sud Amiens
city: Angers
country: France
facility: CHU Angers
city: Besançon
country: France
facility: CHU Besançon
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Créteil
country: France
facility: CHU - Henri Mondor
city: Dijon
country: France
facility: CHU Dijon
city: Grenoble
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Hôpital Croix Rousse
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Montpellier
country: France
facility: CHU Saint Eloi Montpellier
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Orléans
country: France
facility: CHR Orléans
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpêtrière
city: Paris
country: France
facility: Hôpital Ambroise Paré
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Paris
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Pessac
country: France
facility: Hôpital Haut Lévêque
city: Potiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: Hôpital Robert Debré -CHU Reims
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rouen
country: France
facility: CHU Rouen Charles Nicolle
city: Saint-Cloud
country: France
facility: Institut Curie
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
city: Toulouse
country: France
facility: CHU Rangueil
city: Tours
country: France
facility: CHU Tours
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy Site Brabois
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Institut Curie, Saint-Cloud
name: Cindy Neuzillet, Dr
role: PRINCIPAL_INVESTIGATOR
References: