Cholangiocarcinoma, Hepatocellular Carcinoma (HCC)
Conditions
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.
Interventions
Routine care as per site standard.
Sponsors
iOMEDICO AG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Course of treatment (treatment reality). | 3 years per patient. | Documentation of anamnestic data and therapy sequences. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 \[European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high score for scales and single items represents a high level of symptomatology or problems\]. |
Countries
Germany
Contacts
STUDY_CHAIRThomas Berg, Prof.Dr.
Leipzig
STUDY_CHAIRPeter R. Galle, Prof.Dr.
Mainz
STUDY_CHAIRWolf P. Hofmann, Prof.Dr.
Berlin
STUDY_CHAIRAchim Kautz
Köln
STUDY_CHAIRPhilippe Pereira, Prof.Dr.
Heilbronn
STUDY_CHAIRKarin Potthoff, Dr.
Freiburg im Breisgau
STUDY_CHAIRJan Schröder, PD Dr.
Mülheim an der Ruhr
STUDY_CHAIRRobert Thimme, Prof.Dr.
Freiburg im Breisgau
Outcome results
None listed