Clinical trial NCT04896931: New Prospective Expanded German Registry of Incidental Gallbladder Carcinoma (PERSUASION)- a Permanent Platform Including All Kind of Biliary Tract Cancers (BTC)
Official title: New Prospective Expanded German Registry of Incidental Gallbladder Carcinoma (PERSUASION)- a Permanent Platform Including All Kind of Biliary Tract Cancers (BTC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Biliary Tract Cancer
Neoadjuvant, Adjuvant and 1st Line
Keywords: biliary tract cancer
registry
molecular profiling
Lead sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Primary outcomes:
measure: Establishment of BTC population
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: analyse potential risk factors associated with BTC-cancer
timeFrame: Through study completion, an average of 2 years
measure: The course of Quality of Life (QoL) throughout the entire course of therapy for patients with BTC
timeFrame: Through study completion, an average of 2 years
measure: PFS
timeFrame: Through study completion, an average of 2 years
measure: DFS
timeFrame: Through study completion, an average of 2 years
measure: OS
timeFrame: Through study completion, an average of 2 years
measure: mortality
timeFrame: Through study completion, an average of 2 years
measure: morbidity
timeFrame: Through study completion, an average of 2 years
measure: establishment of sample collection (tumorblocks and blood)
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
state: Baden-Württemberg
city: Ostfildern
country: Germany
facility: Medius Klinik Ostfildern-Ruit
state: Baden-Württemberg
city: Amberg
country: Germany
facility: Klinikum St. Marien Amberg
state: Bayern
city: Dachau
country: Germany
facility: Helios Amper-Klinikum Dachau
state: Bayern
city: Deggendorf
country: Germany
facility: Donau-Isar-Klinikum Deggendorf
state: Bayern
city: Landshut
country: Germany
facility: ÜBAG-Medizinisches Versorgungszentrum. Dr. Vehling-Kaiser GmbH
state: Bayern
city: München
country: Germany
facility: LMU Klinikum Campus Großhadern
state: Bayern
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
state: Bayern
city: Bad Saarow
country: Germany
facility: HELIOS Klinikum Bad Saarow
state: Brandenburg
city: Cottbus
country: Germany
facility: Ambulantes Zentrum für Hämatologie und Onkologie
state: Brandenburg
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen
state: Hessen
city: Rostock
country: Germany
facility: Klinikum Südstadt Rostock
state: Mecklenburg-Vorpommern
city: Hildesheim
country: Germany
facility: St. Bernward Krankenhaus Hildesheim
state: Niedersachsen
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
state: Niedersachsen
city: Krefeld
country: Germany
facility: Krankenhaus Maria-Hilf Krefeld
state: Nordrhein-Westfalen
city: Lemgo
country: Germany
facility: Klinikum Lippe Lemgo
state: Nordrhein-Westfalen
city: Speyer
country: Germany
facility: Onkologische Schwerpunktpraxis Speyer
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: Onkozentrum Dresden
state: Sachsen
city: Freital
country: Germany
facility: Onkologische Schwerpunktpraxis Freital
state: Sachsen
city: Leipzig
country: Germany
facility: Universitäres Krebszentrum Universitätsklinikum Leipzig (UCCL)
state: Sachsen
city: Naunhof
country: Germany
facility: Onkologische Schwerpunktpraxis
state: Sachsen
city: Riesa
country: Germany
facility: Elblandklinikum Riesa
state: Sachsen
city: Erfurt
country: Germany
facility: Gemeinschaftspraxis für Onkologie und Hämatologie
state: Thüringen
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest GmbH
Study officials:
affiliation: Krankenhaus Nordwest GmbH
name: Thorsten Götze, PD Dr.
role: STUDY_DIRECTOR
References: