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

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT04896931

PERSUASION

Details and patient eligibility

About

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.

Full 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

Enrollment: 159 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.