NCT05935189

Brief Summary

The goal of the study is to establish a cancer registry to facilitate research and assist in the identification of additional risk factors for hepatocellular carcinoma. The main objectives are:

  1. 1.provide a mechanism to store the information about subjects with hepatocellular carcinoma
  2. 2.use of tissue samples for translational/further research purposes

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Jul 2023Jul 2028

First Submitted

Initial submission to the registry

June 20, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

July 7, 2023

Status Verified

June 1, 2023

Enrollment Period

5 years

First QC Date

June 20, 2023

Last Update Submit

June 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Creation of a registry

    The primary outcome of this study is to provide a mechanism to store the information about subjects with hepatocellular carcinoma. The outcome will be measured by the number of patients involved in the registry, measured by absolute numbers. The target number is 500 patients.

    5 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is composed of individuals from Armenian descent who have a biopsy-confirmed diagnosis of hepatocellular carcinoma.

You may qualify if:

  • Patients with biopsy-confirmed diagnosis of HCC
  • Armenian descent
  • Having given their signed Informed consent

You may not qualify if:

  • Failure to obtain informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nikomed Medical Center

Yerevan, Armenia

RECRUITING

Related Publications (1)

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PMID: 33538338BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

i. Tumor and liver tissue samples resulting from surgical/biopsy resection ii. 10 mL of whole blood collected on EDTA iii. Stool samples for further gut microbiota profiling

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Hasmik Ghazinian, MD

    Nikomed Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tigran Aghabekyan

CONTACT

Hasmik Ghazinian, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2023

First Posted

July 7, 2023

Study Start

July 1, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

July 7, 2023

Record last verified: 2023-06

Locations