Liver Cancer Registry Platform

Recruiting

• Conditions: Hepatocellular Carcinoma (HCC); Cholangiocarcinoma
• Interventions: Other: Physician's choice according to patient's needs.

• Registration Number: NCT04510740
• Lead Sponsor: iOMEDICO AG

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.

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 Timeline

• Study Start: 2020-08-09
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-14
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cholangiocarcinoma (CCC)	Physician's choice according to patient's needs.	Patients with Cholangiocarcinoma (CCC)
Hepatocellular Carcinoma (HCC)	Physician's choice according to patient's needs.	Patients with Hepatocellular Carcinoma (HCC)

Primary Outcome Measures

Name	Time	Method
Course of treatment (treatment reality).	3 years per patient.	Documentation of anamnestic data and therapy sequences.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Multiple sites all over germany; 🇩🇪 Multiple Locations, Germany