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Active, not recruitingNCT04510740JADEUpdated Aug 25, 2026

Liver Cancer Registry Platform

An observational study in Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma, sponsored by iOMEDICO AG. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by iOMEDICO AG · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Hepatocellular Carcinoma (HCC)
  • Cholangiocarcinoma
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In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 953 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 200 across 752 observational studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

iOMEDICO AG is the lead sponsor of 52 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • Hepatocellular Carcinoma (HCC)

    Patients with Hepatocellular Carcinoma (HCC)

    Other: Physician's choice according to patient's needs.

  • Cholangiocarcinoma (CCC)

    Patients with Cholangiocarcinoma (CCC)

    Other: Physician's choice according to patient's needs.

Interventions

  • OtherPhysician's choice according to patient's needs.

    Routine care as per site standard.

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What researchers measure

Primary outcomes

  1. Course of treatment (treatment reality).

    Documentation of anamnestic data and therapy sequences.

    Time frame: 3 years per patient.

Secondary outcomes

  1. Best Response.

    Documentation of response rates per line of treatment.

    Time frame: 3 years per patient.

  2. Progression-free survival.

    Documentation of progression-free survival per line of treatment.

    Time frame: 3 years per patient.

  3. Overall survival.

    Documentation of overall survival per line of treatment.

    Time frame: 3 years per patient.

  4. Health-related quality of life (Patient-reported outcome, PRO).

    EORTC QLQ-C30 core questionnaire \[European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high scale score represents a higher response level: (a) global health status: a high score represents high quality of life, (b) functional scales: a high score represents high/healthy level of functioning, (c) symptom scales/items: a high score represents high level of symptomatology or problems\]

    Time frame: 3 years per patient.

  5. Carcinoma Health-related quality of life (Patient-reported outcome, PRO).

    EORTC QLQ-HCC18, the hepatocellular carcinoma specific module / EORTC QLQ-BIL21, the cholangiocarcinoma specific module \[European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high score for scales and single items represents a high level of symptomatology or problems\].

    Time frame: 3 years per patient.

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Study locations

1 site
  • Multiple sites all over germany
    Multiple Sites, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04510740
Lead sponsor
iOMEDICO AG
Responsible party
Sponsor
First posted
Aug 12, 2020
Start date
Aug 9, 2020
Primary completion
Sep 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 25, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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