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JOURNAL ONKOLOGIE – STUDIE
JADE

Liver Cancer Registry Platform

Rekrutierend

NCT-Nummer:
NCT04510740

Studienbeginn:
August 2020

Letztes Update:
03.10.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Cholangiocarcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
iOMEDICO AG

Collaborator:
-

Studienleiter

Thomas Berg, Prof.Dr.
Study Chair
Leipzig
Peter R. Galle, Prof.Dr.
Study Chair
Mainz
Wolf P. Hofmann, Prof.Dr.
Study Chair
Berlin
Achim Kautz
Study Chair
Köln
Philippe Pereira, Prof.Dr.
Study Chair
Heilbronn
Karin Potthoff, Dr.
Study Chair
Freiburg im Breisgau
Jan Schröder, PD Dr.
Study Chair
Mülheim an der Ruhr
Robert Thimme, Prof.Dr.
Study Chair
Freiburg im Breisgau

Kontakt

Studienlocations
(1 von 1)

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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)

Studien-Rationale

Primary outcome:

1. Course of treatment (treatment reality). (Time Frame - 3 years per patient.):
Documentation of anamnestic data and therapy sequences.



Secondary outcome:

1. Best Response. (Time Frame - 3 years per patient.):
Documentation of response rates per line of treatment.

2. Progression-free survival. (Time Frame - 3 years per patient.):
Documentation of progression-free survival per line of treatment.

3. Overall survival. (Time Frame - 3 years per patient.):
Documentation of overall survival per line of treatment.

4. Health-related quality of life (Patient-reported outcome, PRO). (Time Frame - 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]

5. Carcinoma Health-related quality of life (Patient-reported outcome, PRO). (Time Frame - 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].

Studien-Arme

  • Hepatocellular Carcinoma (HCC)
    Patients with Hepatocellular Carcinoma (HCC)
  • Cholangiocarcinoma (CCC)
    Patients with Cholangiocarcinoma (CCC)

Geprüfte Regime

  • Physician's choice according to patient's needs.:
    Routine care as per site standard.

Quelle: ClinicalTrials.gov


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