Liver Cancer Registry Platform (JADE)

iOMEDICO

Status: Enrolling

Conditions: Cholangiocarcinoma; Hepatocellular Carcinoma (HCC)

Treatments: Other: Physician's choice according to patient's needs.

Study type: Observational

Funder types: Industry

Identifiers

NCT04510740

IOM-100425

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,000 participants in 2 patient groups

Hepatocellular Carcinoma (HCC)

Description:

Patients with Hepatocellular Carcinoma (HCC)

Treatment:

Other: Physician's choice according to patient's needs.

Cholangiocarcinoma (CCC)

Description:

Patients with Cholangiocarcinoma (CCC)

Treatment:

Other: Physician's choice according to patient's needs.