New Prospective Expanded German Registry of Incidental Gallbladder Carcinoma (PERSUASION)- a Permanent Platform Including All Kind of Biliary Tract Cancers (BTC)

NCT ID: NCT04896931

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 159 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-12
• Study Completion Date: 2025-12-31

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

Conditions

Biliary Tract Cancer; Neoadjuvant, Adjuvant and 1st Line

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thorsten Götze, PD Dr.

Role: STUDY_DIRECTOR

Krankenhaus Nordwest GmbH

Locations

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

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

Universitätsklinikum Gießen

Giessen, Hesse, Germany

St. Bernward Krankenhaus Hildesheim

Hildesheim, Lower Saxony, Germany

Klinikum Oldenburg

Oldenburg, Lower Saxony, Germany

Klinikum Südstadt Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Krankenhaus Maria-Hilf Krefeld

Krefeld, North Rhine-Westphalia, Germany

Klinikum Lippe Lemgo

Lemgo, North Rhine-Westphalia, Germany

Onkologische Schwerpunktpraxis Speyer

Speyer, Rhineland-Palatinate, Germany

Onkozentrum Dresden

Dresden, Saxony, Germany

Onkologische Schwerpunktpraxis Freital

Freital, Saxony, Germany

Universitäres Krebszentrum Universitätsklinikum Leipzig (UCCL)

Leipzig, Saxony, Germany

Onkologische Schwerpunktpraxis

Naunhof, Saxony, Germany

Elblandklinikum Riesa

Riesa, Saxony, Germany

Gemeinschaftspraxis für Onkologie und Hämatologie

Erfurt, Thuringia, Germany

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Krankenhaus Nordwest GmbH

Frankfurt, , Germany

Countries

Germany

Other Identifiers

PERSUASION

Identifier Type: -

Identifier Source: org_study_id