Plattform för levercancerregistret (JADE)
JADE – Clinical Research Platform on Treatment and Outcome in Patients with Hepatocellular eller Cholangiocellular Cancer
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
-
-
-
Multiple Sites, Tyskland
- Multiple sites all over germany
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Adult patients with hepatocellular carcinoma (HCC), or cholangiocarcinoma (CCC) starting treatment for early, intermediate or advanced disease
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: OTHER
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Hepatocellular Carcinoma (HCC)
Patients with Hepatocellular Carcinoma (HCC) |
Routine care as per site standard. |
|
Cholangiocarcinoma (CCC)
Patients with Cholangiocarcinoma (CCC) |
Routine care as per site standard. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Course of treatment (treatment reality).
Tidsram: 3 years per patient.
|
Documentation of anamnestic data and therapy sequences. |
3 years per patient.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Best Response.
Tidsram: 3 years per patient.
|
Documentation of response rates per line of treatment. |
3 years per patient.
|
|
Progression-free survival.
Tidsram: 3 years per patient.
|
Documentation of progression-free survival per line of treatment. |
3 years per patient.
|
|
Overall survival.
Tidsram: 3 years per patient.
|
Documentation of overall survival per line of treatment. |
3 years per patient.
|
|
Health-related quality of life (Patient-reported outcome, PRO).
Tidsram: 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] |
3 years per patient.
|
|
Carcinoma Health-related quality of life (Patient-reported outcome, PRO).
Tidsram: 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]. |
3 years per patient.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Thomas Berg, Prof.Dr., Leipzig
- Studiestol: Peter R. Galle, Prof.Dr., Mainz
- Studiestol: Wolf P. Hofmann, Prof.Dr., Berlin
- Studiestol: Achim Kautz, Köln
- Studiestol: Philippe Pereira, Prof.Dr., Heilbronn
- Studiestol: Karin Potthoff, Dr., Freiburg im Breisgau
- Studiestol: Jan Schröder, PD Dr., Mülheim an der Ruhr
- Studiestol: Robert Thimme, Prof.Dr., Freiburg im Breisgau
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IOM-100425
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