JADE - Clinical Research Platform on Treatment and Outcome in Patients With Hepatocellular or Cholangiocellular Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma (HCC)
- Sponsor
- iOMEDICO AG
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Course of treatment (treatment reality).
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with Hepatocellular Carcinoma (HCC) or Cholangiocarcinoma (CCC) in Germany.
Detailed Description
JADE is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of HCC or CCC in Germany. The registry will follow patients for up to three years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. Health-related quality of life in patients with HCC / CCC will be evaluated for up to three years.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Course of treatment (treatment reality).
Time Frame: 3 years per patient.
Documentation of anamnestic data and therapy sequences.
Secondary Outcomes
- Progression-free survival.(3 years per patient.)
- Best Response.(3 years per patient.)
- Overall survival.(3 years per patient.)
- Carcinoma Health-related quality of life (Patient-reported outcome, PRO).(3 years per patient.)
- Health-related quality of life (Patient-reported outcome, PRO).(3 years per patient.)