Registry for patients with biliary tract cancer in Germany
New Prospective Expanded German Registry of Incidental Gallbladder Carcinoma (PERSUASION)- a Permanent Platform Including All Kind of Biliary Tract Cancers (BTC)
This study is setting up a long-term registry to collect information about people with biliary tract cancer in Germany to help improve treatments and understand their experiences better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Academic / other |
| Locations | 25 sites (Freiburg, Baden-Württemberg and 24 other locations) |
| Trial ID | NCT04896931 on ClinicalTrials.gov |
What this trial studies
This is a permanent, prospective, multicenter registry aimed at collecting comprehensive data on patients with biliary tract cancers, including various oncological therapy lines and clinical outcomes. The registry will gather information on patient characteristics, treatment regimens, and quality of life through patient-reported outcomes. It will also facilitate translational research by biobanking tissue samples for future studies. The primary goal is to establish a representative patient population for ongoing and future research in the DACH region.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with known biliary tract cancer who are planned for or have recently started neoadjuvant, adjuvant, or first-line therapy.
Not a fit: Patients unable to consent or those receiving second-line or further palliative therapies without documented first-line treatment will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of biliary tract cancers and improve treatment strategies and patient outcomes.
How similar studies have performed: While similar registries have been established, this specific approach focusing on biliary tract cancers in the DACH region is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Freiburg, Baden-Württemberg and 24 other locations
- Universitätsklinikum Freiburg — Freiburg, Baden-Württemberg, Germany (Recruiting)
- Medius Klinik Ostfildern-Ruit — Ostfildern, Baden-Württemberg, Germany (Recruiting)
- Klinikum St. Marien Amberg — Amberg, Bayern, Germany (Recruiting)
- Helios Amper-Klinikum Dachau — Dachau, Bayern, Germany (Recruiting)
- Donau-Isar-Klinikum Deggendorf — Deggendorf, Bayern, Germany (Recruiting)
- ÜBAG-Medizinisches Versorgungszentrum. Dr. Vehling-Kaiser GmbH — Landshut, Bayern, Germany (Recruiting)
- LMU Klinikum Campus Großhadern — München, Bayern, Germany (Recruiting)
- Universitätsklinikum Würzburg — Würzburg, Bayern, Germany (Recruiting)
- HELIOS Klinikum Bad Saarow — Bad Saarow, Brandenburg, Germany (Recruiting)
- Ambulantes Zentrum für Hämatologie und Onkologie — Cottbus, Brandenburg, Germany (Recruiting)
- Universitätsklinikum Gießen — Gießen, Hessen, Germany (Recruiting)
- Klinikum Südstadt Rostock — Rostock, Mecklenburg-Vorpommern, Germany (Recruiting)
- St. Bernward Krankenhaus Hildesheim — Hildesheim, Niedersachsen, Germany (Recruiting)
- Klinikum Oldenburg — Oldenburg, Niedersachsen, Germany (Recruiting)
- Krankenhaus Maria-Hilf Krefeld — Krefeld, Nordrhein-Westfalen, Germany (Recruiting)
- Klinikum Lippe Lemgo — Lemgo, Nordrhein-Westfalen, Germany (Recruiting)
- Onkologische Schwerpunktpraxis Speyer — Speyer, Rheinland-Pfalz, Germany (Recruiting)
- Onkozentrum Dresden — Dresden, Sachsen, Germany (Recruiting)
- Onkologische Schwerpunktpraxis Freital — Freital, Sachsen, Germany (Recruiting)
- Universitäres Krebszentrum Universitätsklinikum Leipzig (UCCL) — Leipzig, Sachsen, Germany (Recruiting)
- Onkologische Schwerpunktpraxis — Naunhof, Sachsen, Germany (Recruiting)
- Elblandklinikum Riesa — Riesa, Sachsen, Germany (Recruiting)
- Gemeinschaftspraxis für Onkologie und Hämatologie — Erfurt, Thüringen, Germany (Recruiting)
- Charité - Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
- Krankenhaus Nordwest GmbH — Frankfurt, Germany (Recruiting)
Study contacts
- Study coordinator: Thorsten Götze, PD Dr.
- Email: goetze.thorsten@KHNW.de
- Phone: 0049 69 7601 4187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.