Biliary Tract Cancer, Neoadjuvant, Adjuvant and 1st Line
Conditions
Keywords
biliary tract cancer, registry, molecular profiling
Brief summary
Permanent, prospective, multicenter registry including all kind of oncological therapy lines and procedures, clinical outcome, translational research (biobanking) and QoL for all types of biliary tract cancers.
Detailed description
Permanent, prospective, multicenter registry including all kind of oncological therapy lines and procedures, clinical outcome, translational research (biobanking) and QoL for all types of biliary tract cancers. The registry does not define any medical intervention and does not evaluate the efficacy or safety of the treatment decision made by the investigator. Every adverse event whether related to a treatment or not, will neither be documented in the trial´s eCRF nor be reported to the leading investigators of this study. Objectives: • To establish a registry with a representative BTC-patient population in German-speaking Europe (mainly DACH region) for current and future research. The study registry is not based on a primary endpoint. The data collection includes (among basic patient-/tumor-/treatment- characteristics) the survey of quality of life (EORTC-C30), a so-called patient-reported outcome (PRO) and - if available - the collection of tissue samples for translational accompanying projects. * Clinical data: * To analyse potential risk factors associated with BTC-cancer addressing clinical and biological predictors of treatment success and survival * To determine the course of disease and QoL throughout all applied therapy lines for patients with BTC * To measure progression-free, disease-free and overall survival in different BTC sub-groups, mortality and morbidity for perioperative and palliative therapy procedures * Recording of the therapy regimens and therapy sequences used across all treatment lines * Molecular data (Data- and Biobanking): * To establish a sample collection for future molecular/genetic biomarker characterization to enable for e.g. assessment of the frequency of targetable mutations and associated therapy decisions or progression analysis in baseline and follow-up investigations
Interventions
None listed
Sponsors
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Known biliary-tract cancer including intrahepatic-, extrahepatic- and gallbladder carcinomas * age ≥18 years * signed informed consent form * planned for (or recently started - i.e. within the last 21 days)) neoadjuvant, adjuvant or 1st line therapy
Exclusion criteria
* Patients who are unable to consent because they do not understand the nature, significance and implications of the registry and therefore cannot form a rational intention * Patient under 18 years of age * Patient's inability to complete QoL questionnaire or answer the questions. * Second-line or further palliative therapies if the patient's first-line therapy was not documented within the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Establishment of BTC population | Through study completion, an average of 2 years | To establish a representative BTC-patient population in German-speaking Europe in an agile platform study design for future research |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The course of Quality of Life (QoL) throughout the entire course of therapy for patients with BTC | Through study completion, an average of 2 years | EORTC-QLQC30 according to EORTC scoring manual |
| PFS | Through study completion, an average of 2 years | progression-free survival in different BTC subgroups and therapy lines. As for the main objective, there is no formal secondary endpoint in a registry study. Therfore, in this section we will explain the main data to be collected and the main outcome measures. |
| DFS | Through study completion, an average of 2 years | disease-free survival in different BTC subgroups and therapy lines. As for the main objective, there is no formal secondary endpoint in a registry study. Therfore, in this section we will explain the main data to be collected and the main outcome measures. |
| analyse potential risk factors associated with BTC-cancer | Through study completion, an average of 2 years | Correlate medical history with patient outcome, find prevalent medical history associated with BTC chancer |
| mortality | Through study completion, an average of 2 years | mortality for perioperative and palliative therapy procedures |
| morbidity | Through study completion, an average of 2 years | morbidity for perioperative and palliative therapy procedures |
| establishment of sample collection (tumorblocks and blood) | Through study completion, an average of 2 years | establish a sample collection for future molecular/genetic biomarker characterization |
| OS | Through study completion, an average of 2 years | overall survival in different BTC subgroups and therapy lines. As for the main objective, there is no formal secondary endpoint in a registry study. Therfore, in this section we will explain the main data to be collected and the main outcome measures. |
Countries
Germany
Outcome results
None listed