Biliary Tract Cancer
Conditions
Keywords
predictive, prognostic, biliary track cancer
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).
Interventions
None listed
Sponsors
GERCOR - Multidisciplinary Oncology Cooperative Group
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients with advanced bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months | Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years) | 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
| Measure | Time frame | Description |
|---|---|---|
| Response rate | Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years) | Assessment of treatments effects on the response rate (RECIST v 1.1, Choi). |
| Effect of treatments on secondary resection rate R0 of the primary tumor | From day of surgical intervention until 30 days | Assessment of treatments on secondary resection rate R0 of the primary tumor |
| Effects of treatments on disease-free survival (DFS) | Up to 10 years; The months between surgery and the first documented recurrence, second cancer, or death from any cause | Assessment of treatments effects on disease-free survival (DFS) in patients who underwent surgery. |
| Rate of patients with localized bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months | Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years) | 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. |
| Toxicities (Adverse events) experienced by patients | Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years) | Evaluation of toxicity assessed by CTCAE v 5.0 |
| The complications and postoperative mortality rates in patients who underwent surgery | From day of surgical intervention until 30 days; up to 10 years | Assessment of the complications rate (Clavien classification) and of postoperative mortality in patients who underwent surgery |
| Effects of treatments on progression-free survival (PFS) | Up to 10 years; The months between the start of treatment and the first progression or death, whatever be the cause | Assessment of treatments effects on progression-free survival (PFS) in non-operated patients |
Countries
France
Contacts
Primary ContactCindy Neuzillet, Dr
Backup ContactMarie-Line Garcia, Dr
Outcome results
None listed