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

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.

Study Overview

• Status: Completed
• Conditions: Biliary Tract Cancer; Neoadjuvant, Adjuvant and 1st Line

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

• Study Type: Observational
• Enrollment (Actual): 159

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin
  • Frankfurt, Germany, 60488
    • Krankenhaus Nordwest GmbH
  • Baden-Wurttemberg
    • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 49106
      • Universitatsklinikum Freiburg
    • Ostfildern, Baden-Wurttemberg, Germany, 73760
      • Medius Klinik Ostfildern-Ruit
  • Bavaria
    • Amberg, Bavaria, Germany, 92224
      • Klinikum St. Marien Amberg
    • Dachau, Bavaria, Germany, 85221
      • Helios Amper-Klinikum Dachau
    • Deggendorf, Bavaria, Germany, 94469
      • Donau-Isar-Klinikum Deggendorf
    • Landshut, Bavaria, Germany, 84036
      • ÜBAG-Medizinisches Versorgungszentrum. Dr. Vehling-Kaiser GmbH
    • München, Bavaria, Germany, 81377
      • LMU Klinikum Campus Großhadern
    • Würzburg, Bavaria, Germany, 97080
      • Universitatsklinikum Wurzburg
  • Brandenburg
    • Bad Saarow, Brandenburg, Germany, 15526
      • Helios Klinikum Bad Saarow
    • Cottbus, Brandenburg, Germany, 03046
      • Ambulantes Zentrum für Hämatologie und Onkologie
  • Hesse
    • Giessen, Hesse, Germany, 35392
      • Universitätsklinikum Gießen
  • Lower Saxony
    • Hildesheim, Lower Saxony, Germany, 31134
      • St. Bernward Krankenhaus Hildesheim
    • Oldenburg, Lower Saxony, Germany, 26133
      • Klinikum Oldenburg
  • Mecklenburg-Vorpommern
    • Rostock, Mecklenburg-Vorpommern, Germany, 18059
      • Klinikum Südstadt Rostock
  • North Rhine-Westphalia
    • Krefeld, North Rhine-Westphalia, Germany, 47805
      • Krankenhaus Maria-Hilf Krefeld
    • Lemgo, North Rhine-Westphalia, Germany, 32657
      • Klinikum Lippe Lemgo
  • Rhineland-Palatinate
    • Speyer, Rhineland-Palatinate, Germany, 67346
      • Onkologische Schwerpunktpraxis Speyer
  • Saxony
    • Dresden, Saxony, Germany, 01127
      • Onkozentrum Dresden
    • Freital, Saxony, Germany, 01705
      • Onkologische Schwerpunktpraxis Freital
    • Leipzig, Saxony, Germany, 04103
      • Universitäres Krebszentrum Universitätsklinikum Leipzig (UCCL)
    • Naunhof, Saxony, Germany, 04683
      • Onkologische Schwerpunktpraxis
    • Riesa, Saxony, Germany, 01589
      • Elblandklinikum Riesa
  • Thuringia
    • Erfurt, Thuringia, Germany, 99085
      • Gemeinschaftspraxis für Onkologie und Hämatologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishment of BTC population	To establish a representative BTC-patient population in German-speaking Europe in an agile platform study design for future research	Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analyse potential risk factors associated with BTC-cancer	Correlate medical history with patient outcome, find prevalent medical history associated with BTC chancer	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	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.	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.	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.	Through study completion, an average of 2 years
mortality	mortality for perioperative and palliative therapy procedures	Through study completion, an average of 2 years
morbidity	morbidity for perioperative and palliative therapy procedures	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	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
• Investigators: Study Director: Thorsten Götze, PD Dr., Krankenhaus Nordwest GmbH

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: biliary tract cancer; registry; molecular profiling
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Biliary Tract Diseases; Biliary Tract Neoplasms
• Other Study ID Numbers: PERSUASION

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No