Liver Cancer Registry Platform
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsoriOMEDICO AG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed hepatocellular carcinoma (HCC) or cholangiocarcinoma (CCC) als early, intermediate or advanced/metastatic stage
Age ≥ 18 years
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
Disqualifiers
None
Trial population
Adult patients with hepatocellular carcinoma (HCC), or cholangiocarcinoma (CCC) starting treatment for early, intermediate or advanced disease
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Physician's choice according to patient's needs.
Other interventionRoutine care as per site standard.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Hepatocellular Carcinoma (HCC)1 intervention
Group B: Cholangiocarcinoma (CCC)1 intervention
Trial outcomes
Primary outcomes
1
Course of treatment (treatment reality).
Documentation of anamnestic data and therapy sequences.
Time frame
3 years per patient.Secondary outcomes
1
Best Response.
Documentation of response rates per line of treatment.
Time frame
3 years per patient.2
Progression-free survival.
Documentation of progression-free survival per line of treatment.
Time frame
3 years per patient.3
Overall survival.
Documentation of overall survival per line of treatment.
Time frame
3 years per patient.4
Health-related quality of life (Patient-reported outcome, PRO).
EORTC QLQ-C30 core questionnaire \[European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high scale score represents a higher response level: (a) global health status: a high score represents high quality of life, (b) functional scales: a high score represents high/healthy level of functioning, (c) symptom scales/items: a high score represents high level of symptomatology or problems\]
Time frame
3 years per patient.Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Multiple sites all over germanyRecruiting Multiple Sites
Germany
GermanySponsors and contacts
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Source ClinicalTrials.gov