JADE: Liver Cancer Registry Platform
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | 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
Primary Outcome Measures
- Course of treatment (treatment reality). [3 years per patient.]
Documentation of anamnestic data and therapy sequences.
Secondary Outcome Measures
- Best Response. [3 years per patient.]
Documentation of response rates per line of treatment.
- Progression-free survival. [3 years per patient.]
Documentation of progression-free survival per line of treatment.
- Overall survival. [3 years per patient.]
Documentation of overall survival per line of treatment.
- 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]
- 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].
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Multiple sites all over germany | Multiple Locations | Germany |
Sponsors and Collaborators
- iOMEDICO AG
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IOM-100425