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RecruitingNCT04935853

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
1,350 (estimated)
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Timeline

Start date
2022-05-23
Primary completion
2030-06-01
Completion
2040-06-01
First posted
2021-06-23
Last updated
2025-07-23

Locations

32 sites across 1 country: France

Source: ClinicalTrials.gov record NCT04935853. Inclusion in this directory is not an endorsement.