Liver Cancer Registry Platform
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physician's choice according to patient's needs..
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma (HCC), Cholangiocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
JADE - Clinical Research Platform on Treatment and Outcome in Patients With Hepatocellular or Cholangiocellular Cancer
Overview
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.
Interventions
- Other Physician's choice according to patient's needs.
Routine care as per site standard.
Primary outcome measures
- Course of treatment (treatment reality). [Time frame: 3 years per patient.]
Secondary outcome measures (5)
- Best Response. [Time frame: 3 years per patient.]
- Progression-free survival. [Time frame: 3 years per patient.]
- Overall survival. [Time frame: 3 years per patient.]
- Health-related quality of life (Patient-reported outcome, PRO). [Time frame: 3 years per patient.]
- Carcinoma Health-related quality of life (Patient-reported outcome, PRO). [Time frame: 3 years per patient.]
Eligibility criteria
Inclusion criteria
- Confirmed hepatocellular carcinoma (HCC) or cholangiocarcinoma (CCC) als early, intermediate or advanced/metastatic stage
- Age ≥ 18 years
- Signed and dated informed consent (IC):
- For participation in the PRO module: Before primary locoregional therapy or start of first systemic treatment
- For no participation in the PRO module: No later than 8 weeks after primary locoregional therapy or start of first systemic treatment
Exclusion criteria
Patients treated with best supportive care (BSC) only (i.e. no surgery, no radiotherapy, no ablative procedures, no systemic anti-tumoral therapies)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Germany · 1 center
- Multiple sites all over germany — Multiple Sites
Identifiers
NCT: NCT04510740 · IOM-100425