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Biliary Tract CancerNCT04896931

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

An observational study of Biliary Tract Cancer and Neoadjuvant, Adjuvant and 1st Line, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 25 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
159 participants
Where
25 sitesGermany
Study dates
12 Jul 2022to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Germany25 sites

  • Klinikum St. Marien Amberg

    Amberg, Bavaria, 92224

  • HELIOS Klinikum Bad Saarow

    Bad Saarow, Brandenburg, 15526

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Ambulantes Zentrum für Hämatologie und Onkologie

    Cottbus, Brandenburg, 03046

  • Helios Amper-Klinikum Dachau

    Dachau, Bavaria, 85221

  • Donau-Isar-Klinikum Deggendorf

    Deggendorf, Bavaria, 94469

  • Onkozentrum Dresden

    Dresden, Saxony, 01127

  • Gemeinschaftspraxis für Onkologie und Hämatologie

    Erfurt, Thuringia, 99085

  • Krankenhaus Nordwest GmbH

    Frankfurt, 60488

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 49106

  • Onkologische Schwerpunktpraxis Freital

    Freital, Saxony, 01705

  • Universitätsklinikum Gießen

    Giessen, Hesse, 35392

  • St. Bernward Krankenhaus Hildesheim

    Hildesheim, Lower Saxony, 31134

  • Krankenhaus Maria-Hilf Krefeld

    Krefeld, North Rhine-Westphalia, 47805

  • ÜBAG-Medizinisches Versorgungszentrum. Dr. Vehling-Kaiser GmbH

    Landshut, Bavaria, 84036

  • Universitäres Krebszentrum Universitätsklinikum Leipzig (UCCL)

    Leipzig, Saxony, 04103

  • Klinikum Lippe Lemgo

    Lemgo, North Rhine-Westphalia, 32657

  • LMU Klinikum Campus Großhadern

    München, Bavaria, 81377

  • Onkologische Schwerpunktpraxis

    Naunhof, Saxony, 04683

  • Klinikum Oldenburg

    Oldenburg, Lower Saxony, 26133

  • Medius Klinik Ostfildern-Ruit

    Ostfildern, Baden-Wurttemberg, 73760

  • Elblandklinikum Riesa

    Riesa, Saxony, 01589

  • Klinikum Südstadt Rostock

    Rostock, Mecklenburg-Vorpommern, 18059

  • Onkologische Schwerpunktpraxis Speyer

    Speyer, Rhineland-Palatinate, 67346

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

About this study

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.

Read the 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
Keywords
biliary tract cancer, registry, molecular profiling
Medical subject headings
Biliary Tract Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Establishment of BTC population

    To establish a representative BTC-patient population in German-speaking Europe in an agile platform study design for future research

    Measured: Through study completion, an average of 2 years

Secondary outcomes (8)

  1. analyse potential risk factors associated with BTC-cancer

    Correlate medical history with patient outcome, find prevalent medical history associated with BTC chancer

    Measured: Through study completion, an average of 2 years

  2. The course of Quality of Life (QoL) throughout the entire course of therapy for patients with BTC

    EORTC-QLQC30 according to EORTC scoring manual

    Measured: Through study completion, an average of 2 years

  3. 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.

    Measured: Through study completion, an average of 2 years

  4. 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.

    Measured: Through study completion, an average of 2 years

  5. 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.

    Measured: Through study completion, an average of 2 years

  6. mortality

    mortality for perioperative and palliative therapy procedures

    Measured: Through study completion, an average of 2 years

  7. morbidity

    morbidity for perioperative and palliative therapy procedures

    Measured: Through study completion, an average of 2 years

  8. establishment of sample collection (tumorblocks and blood)

    establish a sample collection for future molecular/genetic biomarker characterization

    Measured: Through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2021
  2. Study start12 Jul 2022
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04896931
Sponsor's protocol ID
PERSUASION
Status last verified
Jan 2026
First submitted
10 May 2021
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Biliary Tract Cancer and Neoadjuvant, Adjuvant and 1st Line, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 25 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Establishment of BTC population (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04896931.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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