Plattform for leverkreftregister (JADE)
JADE – Clinical Research Platform on Treatment and Outcome in Patients with Hepatocellular or 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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
-
-
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Multiple Sites, Tyskland
- Multiple sites all over germany
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Adult patients with hepatocellular carcinoma (HCC), or cholangiocarcinoma (CCC) starting treatment for early, intermediate or advanced disease
Beskrivelse
Inclusion criteria:
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Confirmed hepatocellular carcinoma (HCC) or cholangiocarcinoma (CCC) als early, intermediate or advanced/metastatic stage
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Age ≥ 18 years
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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
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: OTHER
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Course of treatment (treatment reality).
Tidsramme: 3 years per patient.
|
Documentation of anamnestic data and therapy sequences. |
3 years per patient.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Best Response.
Tidsramme: 3 years per patient.
|
Documentation of response rates per line of treatment. |
3 years per patient.
|
|
Progression-free survival.
Tidsramme: 3 years per patient.
|
Documentation of progression-free survival per line of treatment. |
3 years per patient.
|
|
Overall survival.
Tidsramme: 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).
Tidsramme: 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).
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- 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
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IOM-100425
Legemiddel- og utstyrsinformasjon, studiedokumenter
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