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NCT Number: NCT04510740

Liver Cancer Registry Platform

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.

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Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Physician's choice according to patient's needs.

Other

Routine care as per site standard.

Primary outcomes

  1. Course of treatment (treatment reality).

    Time frame: 3 years per patient.

    Documentation of anamnestic data and therapy sequences.

Secondary outcomes

  1. Best Response.

    Time frame: 3 years per patient.

    Documentation of response rates per line of treatment.

  2. Progression-free survival.

    Time frame: 3 years per patient.

    Documentation of progression-free survival per line of treatment.

  3. Overall survival.

    Time frame: 3 years per patient.

    Documentation of overall survival per line of treatment.

  4. 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]

  5. 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].

Study contacts

Contact information is provided by the study sponsor or research team.

iOMEDICO AG

CONTACT

[email protected]

+49 761 15242-0

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Registry information

Official study title

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

Acronym: JADE

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2020
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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