New Prospective Expanded German Registry of Incidental Gallbladder Carcinoma (PERSUASION)- a Permanent Platform Including All Kind of Biliary Tract Cancers (BTC)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 159
- Locations
- 25
- Primary Endpoint
- Establishment of BTC population
Study Overview
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.
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Clinical data:
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To analyse potential risk factors associated with BTC-cancer addressing clinical and biological predictors of treatment success and survival
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To determine the course of disease and QoL throughout all applied therapy lines for patients with BTC
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To measure progression-free, disease-free and overall survival in different BTC sub-groups, mortality and morbidity for perioperative and palliative therapy procedures
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Recording of the therapy regimens and therapy sequences used across all treatment lines
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Molecular data (Data- and Biobanking):
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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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Establishment of BTC population
Time Frame: Through study completion, an average of 2 years
To establish a representative BTC-patient population in German-speaking Europe in an agile platform study design for future research
Secondary Outcomes
- The course of Quality of Life (QoL) throughout the entire course of therapy for patients with BTC(Through study completion, an average of 2 years)
- mortality(Through study completion, an average of 2 years)
- analyse potential risk factors associated with BTC-cancer(Through study completion, an average of 2 years)
- DFS(Through study completion, an average of 2 years)
- OS(Through study completion, an average of 2 years)
- morbidity(Through study completion, an average of 2 years)
- PFS(Through study completion, an average of 2 years)
- establishment of sample collection (tumorblocks and blood)(Through study completion, an average of 2 years)