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.
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
Study Type
OBSERVATIONAL
Enrollment
159
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Establishment of BTC population
To establish a representative BTC-patient population in German-speaking Europe in an agile platform study design for future research
Time frame: Through study completion, an average of 2 years
analyse potential risk factors associated with BTC-cancer
Correlate medical history with patient outcome, find prevalent medical history associated with BTC chancer
Time frame: Through study completion, an average of 2 years
The course of Quality of Life (QoL) throughout the entire course of therapy for patients with BTC
EORTC-QLQC30 according to EORTC scoring manual
Time frame: Through study completion, an average of 2 years
PFS
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.
Time frame: Through study completion, an average of 2 years
DFS
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.
Time frame: Through study completion, an average of 2 years
OS
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.
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Medius Klinik Ostfildern-Ruit
Ostfildern, Baden-Wurttemberg, Germany
Klinikum St. Marien Amberg
Amberg, Bavaria, Germany
Helios Amper-Klinikum Dachau
Dachau, Bavaria, Germany
Donau-Isar-Klinikum Deggendorf
Deggendorf, Bavaria, Germany
ÜBAG-Medizinisches Versorgungszentrum. Dr. Vehling-Kaiser GmbH
Landshut, Bavaria, Germany
LMU Klinikum Campus Großhadern
München, Bavaria, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany
HELIOS Klinikum Bad Saarow
Bad Saarow, Brandenburg, Germany
Ambulantes Zentrum für Hämatologie und Onkologie
Cottbus, Brandenburg, Germany
...and 15 more locations
Time frame: Through study completion, an average of 2 years
mortality
mortality for perioperative and palliative therapy procedures
Time frame: Through study completion, an average of 2 years
morbidity
morbidity for perioperative and palliative therapy procedures
Time frame: Through study completion, an average of 2 years
establishment of sample collection (tumorblocks and blood)
establish a sample collection for future molecular/genetic biomarker characterization
Time frame: Through study completion, an average of 2 years