Clinical trial · Observational
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
NCT04935853CI-TRIAL-00092516recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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)
- description
- 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 outcomes (7)
- 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)
- description
- 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.
- measure
- Response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDNoe C, Henriques J, Chanez B, Vernerey D, Lecomte T, Durand A, Assenat E, Edeline J, Heurgue A, Tougeron D, Manfredi S, Hautefeuille V, Neuzillet C, Roth G, Lagasse JP, Tournigand C, Delaye M, Hollebecque A, Turpin A, Parent P. Adjuvant capecitabine in resected biliary tract cancer: a real-world data from the BILCAP-Real study (ACABi multicentre cohort). JHEP Rep. 2026 Jul 28:101968. doi: 10.1016/j.jhepr.2026.101968. Online ahead of print. PMID 42520930
- DERIVEDAdamus N, Edeline J, Henriques J, Fares N, Lecomte T, Turpin A, Vernerey D, Vincens M, Chanez B, Tougeron D, Tournigand C, Assenat E, Delaye M, Manfredi S, Bouche O, Williet N, Vienot A, Blaise L, Mas L, Neuzillet C, Boileve A, Roth GS. First-line chemotherapy with selective internal radiation therapy for intrahepatic cholangiocarcinoma: The French ACABi GERCOR PRONOBIL cohort. JHEP Rep. 2024 Nov 20;7(2):101279. doi: 10.1016/j.jhepr.2024.101279. eCollection 2025 Feb. PMID 39897613