Liver Cancer Registry Platform

Study Overview
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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.

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

Conditions
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Hepatocellular Carcinoma (HCC), Cholangiocarcinoma

Intervention / Treatment
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* Other: Physician's choice according to patient's needs.


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hepatocellular Carcinoma (HCC)<br>Patients with Hepatocellular Carcinoma (HCC) | Other: Physician's choice according to patient's needs.<br>* Routine care as per site standard.<br>|
| Cholangiocarcinoma (CCC)<br>Patients with Cholangiocarcinoma (CCC) | Other: Physician's choice according to patient's needs.<br>* Routine care as per site standard.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Course of treatment (treatment reality). | Documentation of anamnestic data and therapy sequences. | 3 years per patient. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Response. | Documentation of response rates per line of treatment. | 3 years per patient. | 
| Progression-free survival. | Documentation of progression-free survival per line of treatment. | 3 years per patient. | 
| Overall survival. | Documentation of overall survival per line of treatment. | 3 years per patient. | 
| 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] | 3 years per patient. | 
| 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]. | 3 years per patient. |