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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Patients with Hepatocellular Carcinoma (HCC) |
| |
| Cholangiocarcinoma (CCC) | Patients with Cholangiocarcinoma (CCC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physician's choice according to patient's needs. | Other | Routine care as per site standard. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Course of treatment (treatment reality). | Documentation of anamnestic data and therapy sequences. | 3 years per patient. |
| 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. |
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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):
Exclusion criteria:
Patients treated with best supportive care (BSC) only (i.e. no surgery, no radiotherapy, no ablative procedures, no systemic anti-tumoral therapies)
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Adult patients with hepatocellular carcinoma (HCC), or cholangiocarcinoma (CCC) starting treatment for early, intermediate or advanced disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| iOMEDICO AG | Contact | +49 761 15242-0 | info@iomedico.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Berg, Prof.Dr. | Leipzig | Study Chair |
| Peter R. Galle, Prof.Dr. | Mainz | Study Chair |
| Wolf P. Hofmann, Prof.Dr. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple sites all over germany | Recruiting | Multiple Sites | Germany |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 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. |
| 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 Chair |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |