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.
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
Enrollment
1,350
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)
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)
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)
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
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
Effects of treatments on progression-free survival (PFS)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CHU Hôpital Sud Amiens
Amiens, France
CHU Angers
Angers, France
RECRUITINGCHU Besançon
Besançon, France
RECRUITINGHôpital Avicenne
Bobigny, France
RECRUITINGCHU - Henri Mondor
Créteil, France
RECRUITINGCHU Dijon
Dijon, France
RECRUITINGCHU Grenoble
Grenoble, France
RECRUITINGCHU Lille
Lille, France
RECRUITINGCentre Léon Bérard
Lyon, France
RECRUITINGHôpital Croix Rousse
Lyon, France
RECRUITING...and 22 more locations
Assessment of treatments effects on progression-free survival (PFS) in non-operated patients
Time frame: Up to 10 years; The months between the start of treatment and the first progression or death, whatever be the cause
Toxicities (Adverse events) experienced by patients
Evaluation of toxicity assessed by CTCAE v 5.0
Time frame: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)
The complications and postoperative mortality rates in patients who underwent surgery
Assessment of the complications rate (Clavien classification) and of postoperative mortality in patients who underwent surgery
Time frame: From day of surgical intervention until 30 days; up to 10 years