Brief Title
Liver Cancer Registry Platform
Official Title
JADE - Clinical Research Platform on Treatment and Outcome in Patients With Hepatocellular or Cholangiocellular Cancer
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.
Study Type
Observational [Patient Registry]
Primary Outcome
Course of treatment (treatment reality).
Secondary Outcome
Best Response.
Condition
Hepatocellular Carcinoma (HCC)
Intervention
Physician's choice according to patient's needs.
Study Arms / Comparison Groups
Hepatocellular Carcinoma (HCC)
Description: Patients with Hepatocellular Carcinoma (HCC)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
1000
Start Date
August 9, 2020
Completion Date
December 2026
Primary Completion Date
December 2026
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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Thomas Berg, Prof.Dr., +49 761 15242-0, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT04510740
Organization ID
IOM-100425
Responsible Party
Sponsor
Study Sponsor
iOMEDICO AG
Study Sponsor
Thomas Berg, Prof.Dr., Study Chair, Leipzig
Verification Date
August 2022