Liver Cancer Registry Platform

NCT ID: NCT04510740

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-09

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma (HCC) Cholangiocarcinoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Hepatocellular Carcinoma (HCC)

Patients with Hepatocellular Carcinoma (HCC)

Physician's choice according to patient's needs.

Intervention Type OTHER

Routine care as per site standard.

Cholangiocarcinoma (CCC)

Patients with Cholangiocarcinoma (CCC)

Physician's choice according to patient's needs.

Intervention Type OTHER

Routine care as per site standard.

Interventions

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Physician's choice according to patient's needs.

Routine care as per site standard.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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iOMEDICO AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Berg, Prof.Dr.

Role: STUDY_CHAIR

Leipzig

Peter R. Galle, Prof.Dr.

Role: STUDY_CHAIR

Mainz

Wolf P. Hofmann, Prof.Dr.

Role: STUDY_CHAIR

Berlin

Achim Kautz

Role: STUDY_CHAIR

Köln

Philippe Pereira, Prof.Dr.

Role: STUDY_CHAIR

Heilbronn

Karin Potthoff, Dr.

Role: STUDY_CHAIR

Freiburg im Breisgau

Jan Schröder, PD Dr.

Role: STUDY_CHAIR

Mülheim an der Ruhr

Robert Thimme, Prof.Dr.

Role: STUDY_CHAIR

Freiburg im Breisgau

Locations

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Multiple sites all over germany

Multiple Locations, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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iOMEDICO AG

Role: CONTACT

+49 761 15242-0

Facility Contacts

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iOMEDICO AG

Role: primary

+49 761 152420

Other Identifiers

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IOM-100425

Identifier Type: -

Identifier Source: org_study_id

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