Liver Cancer Registry Platform (JADE)

June 3, 2026 updated by: iOMEDICO AG

JADE - Clinical Research Platform on Treatment and Outcome in Patients With Hepatocellular or Cholangiocellular Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Multiple Sites, Germany
        • Recruiting
        • Multiple sites all over germany
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with hepatocellular carcinoma (HCC), or cholangiocarcinoma (CCC) starting treatment for early, intermediate or advanced disease

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hepatocellular Carcinoma (HCC)
Patients with Hepatocellular Carcinoma (HCC)
Other: Physician's choice according to patient's needs.
Routine care as per site standard.
Cholangiocarcinoma (CCC)
Patients with Cholangiocarcinoma (CCC)
Other: Physician's choice according to patient's needs.
Routine care as per site standard.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Course of treatment (treatment reality).
Time Frame: 3 years per patient.
Documentation of anamnestic data and therapy sequences.
3 years per patient.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Response.
Time Frame: 3 years per patient.
Documentation of response rates per line of treatment.
3 years per patient.
Progression-free survival.
Time Frame: 3 years per patient.
Documentation of progression-free survival per line of treatment.
3 years per patient.
Overall survival.
Time Frame: 3 years per patient.
Documentation of overall survival per line of treatment.
3 years per patient.
Health-related quality of life (Patient-reported outcome, PRO).
Time Frame: 3 years per patient.
EORTC QLQ-C30 core questionnaire [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high scale score represents a higher response level: (a) global health status: a high score represents high quality of life, (b) functional scales: a high score represents high/healthy level of functioning, (c) symptom scales/items: a high score represents high level of symptomatology or problems]
3 years per patient.
Carcinoma Health-related quality of life (Patient-reported outcome, PRO).
Time Frame: 3 years per patient.
EORTC QLQ-HCC18, the hepatocellular carcinoma specific module / EORTC QLQ-BIL21, the cholangiocarcinoma specific module [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high score for scales and single items represents a high level of symptomatology or problems].
3 years per patient.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iOMEDICO AG

Investigators

  • Study Chair: Thomas Berg, Prof.Dr., Leipzig
  • Study Chair: Peter R. Galle, Prof.Dr., Mainz
  • Study Chair: Wolf P. Hofmann, Prof.Dr., Berlin
  • Study Chair: Achim Kautz, Köln
  • Study Chair: Philippe Pereira, Prof.Dr., Heilbronn
  • Study Chair: Karin Potthoff, Dr., Freiburg im Breisgau
  • Study Chair: Jan Schröder, PD Dr., Mülheim an der Ruhr
  • Study Chair: Robert Thimme, Prof.Dr., Freiburg im Breisgau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2020

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOM-100425

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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