Liver Cancer Registry Platform (JADE)

  • STATUS
    Recruiting
  • End date
    Dec 20, 2026
  • participants needed
    1000
  • sponsor
    iOMEDICO AG
Updated on 7 October 2022
cancer

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.

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.

Details
Condition Hepatocellular Carcinoma (HCC), Cholangiocarcinoma
Treatment Physician's choice according to patient's needs.
Clinical Study IdentifierNCT04510740
SponsoriOMEDICO AG
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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