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

Study Overview
=================
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).

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

Conditions
-----------------
Biliary Tract Cancer

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
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 | 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 | 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 | 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 | 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) | 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) | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
predictive, prognostic, biliary track cancer