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Liver Cancer Registry Platform (JADE)

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ClinicalTrials.gov Identifier: NCT04510740
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
iOMEDICO AG

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma (HCC) Cholangiocarcinoma Other: Physician's choice according to patient's needs.

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: JADE - Clinical Research Platform on Treatment and Outcome in Patients With Hepatocellular or Cholangiocellular Cancer
Actual Study Start Date : August 9, 2020
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Course of treatment (treatment reality). [ Time Frame: 3 years per patient. ]
    Documentation of anamnestic data and therapy sequences.


Secondary Outcome Measures :
  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].


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510740


Contacts
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Contact: iOMEDICO AG +49 761 15242-0 info@iomedico.com

Locations
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Germany
Multiple sites all over germany Recruiting
Multiple Locations, Germany
Contact: iOMEDICO AG    +49 761 152420    info@iomedico.com   
Sponsors and Collaborators
iOMEDICO AG
Investigators
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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
More Information
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Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT04510740    
Other Study ID Numbers: IOM-100425
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms