Brief Title
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
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 Type
Observational
Primary Outcome
Rate of patients with advanced bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months
Secondary Outcome
Rate of patients with localized bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months
Condition
Biliary Tract Cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
1350
Start Date
June 30, 2021
Completion Date
June 1, 2040
Primary Completion Date
June 1, 2030
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +33 (0)1 47 11 15 15, [email protected]
Administrative Informations
NCT ID
NCT04935853
Organization ID
ACABi PRONOBIL GB-115
Responsible Party
Sponsor
Study Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Study Sponsor
, ,
Verification Date
May 2021