Liver Cancer Registry Platform

NCT04510740 | Recruiting

• 1 other identifier: IOM-100425
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma (HCC); Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Course of treatment (treatment reality).

  Documentation of anamnestic data and therapy sequences.

  3 years per patient.

Secondary Outcomes (5)

• Best Response.

  3 years per patient.

• Progression-free survival.

  3 years per patient.

• Overall survival.

  3 years per patient.

• Health-related quality of life (Patient-reported outcome, PRO).

  3 years per patient.

• Carcinoma Health-related quality of life (Patient-reported outcome, PRO).

  3 years per patient.

Study Arms (2)

Hepatocellular Carcinoma (HCC)

Patients with Hepatocellular Carcinoma (HCC)

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

Cholangiocarcinoma (CCC)

Patients with Cholangiocarcinoma (CCC)

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

Interventions

Physician's choice according to patient's needs. OTHER

Routine care as per site standard.

Cholangiocarcinoma (CCC); Hepatocellular Carcinoma (HCC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with hepatocellular carcinoma (HCC), or cholangiocarcinoma (CCC) starting treatment for early, intermediate or advanced disease

You may qualify if:

• 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

You may not qualify if:

• Patients treated with best supportive care (BSC) only (i.e. no surgery, no radiotherapy, no ablative procedures, no systemic anti-tumoral therapies)

Sponsors & Collaborators

• iOMEDICO AG: lead

Study Sites (1)

Multiple sites all over germany

Multiple Locations, Germany

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Thomas Berg, Prof.Dr.

  Leipzig

  STUDY CHAIR

• Peter R. Galle, Prof.Dr.

  Mainz

  STUDY CHAIR

• Wolf P. Hofmann, Prof.Dr.

  Berlin

  STUDY CHAIR

• Achim Kautz

  Köln

  STUDY CHAIR

• Philippe Pereira, Prof.Dr.

  Heilbronn

  STUDY CHAIR

• Karin Potthoff, Dr.

  Freiburg im Breisgau

  STUDY CHAIR

• Jan Schröder, PD Dr.

  Mülheim an der Ruhr

  STUDY CHAIR

• Robert Thimme, Prof.Dr.

  Freiburg im Breisgau

  STUDY CHAIR

Central Study Contacts

iOMEDICO AG

CONTACT

+49 761 15242-0; info@iomedico.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: August 9, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

DE (1)