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

ConditionBiliary Tract Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGERCOR - Multidisciplinary Oncology Cooperative Group

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

Retro-prospective (diagnosis between 2003 and 2020) and prospective (diagnosis between 2021 and 2030) cohorts of patients with Bile Duct Cancer

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)

Secondary outcomes

1

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.

Time frame
Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)
2

Response rate

Assessment of treatments effects on the response rate (RECIST v 1.1, Choi).

Time frame
Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)
3

Effect of treatments on secondary resection rate R0 of the primary tumor

Assessment of treatments on secondary resection rate R0 of the primary tumor

Time frame
From day of surgical intervention until 30 days
4

Effects of treatments on disease-free survival (DFS)

Assessment of treatments effects on disease-free survival (DFS) in patients who underwent surgery.

Time frame
Up to 10 years; The months between surgery and the first documented recurrence, second cancer, or death from any cause

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GERCOR - Multidisciplinary Oncology Cooperative Group

Lead sponsor

Source ClinicalTrials.gov
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