Clinical trial NCT04510740: Liver Cancer Registry Platform
Official title: JADE - Clinical Research Platform on Treatment and Outcome in Patients With Hepatocellular or Cholangiocellular Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma (HCC)
Cholangiocarcinoma
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2020-08-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with hepatocellular carcinoma (HCC), or cholangiocarcinoma (CCC) starting treatment for early, intermediate or advanced disease

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Course of treatment (treatment reality).
timeFrame: 3 years per patient.
Secondary outcomes:
measure: Best Response.
timeFrame: 3 years per patient.
measure: Progression-free survival.
timeFrame: 3 years per patient.
measure: Overall survival.
timeFrame: 3 years per patient.
measure: Health-related quality of life (Patient-reported outcome, PRO).
timeFrame: 3 years per patient.
measure: Carcinoma Health-related quality of life (Patient-reported outcome, PRO).
timeFrame: 3 years per patient.
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Multiple sites all over germany
Study officials:
affiliation: Leipzig
name: Thomas Berg, Prof.Dr.
role: STUDY_CHAIR
affiliation: Mainz
name: Peter R. Galle, Prof.Dr.
role: STUDY_CHAIR
affiliation: Berlin
name: Wolf P. Hofmann, Prof.Dr.
role: STUDY_CHAIR
affiliation: Köln
name: Achim Kautz
role: STUDY_CHAIR
affiliation: Heilbronn
name: Philippe Pereira, Prof.Dr.
role: STUDY_CHAIR
affiliation: Freiburg im Breisgau
name: Karin Potthoff, Dr.
role: STUDY_CHAIR
affiliation: Mülheim an der Ruhr
name: Jan Schröder, PD Dr.
role: STUDY_CHAIR
affiliation: Freiburg im Breisgau
name: Robert Thimme, Prof.Dr.
role: STUDY_CHAIR
References: