Establishment of a Tissue Registry for Hepatocellular Carcinoma Specimens

NCT ID: NCT05935189

Last Updated: 2023-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2028-07-01

Brief Summary

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

Detailed Description

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The Establishment of a Tissue Registry for Hepatocellular Carcinoma biopsy specimens for genetic and histologic research (TIR-HCC) is a project aimed at addressing the high incidence rates of primary liver cancer in Armenia. This initiative seeks to establish a cancer registry to support research efforts and identify additional risk factors associated with hepatocellular carcinoma (HCC).

The study will involve patients of Armenian descent who exhibit clinical, biochemical, and imaging evidence of hepatocellular carcinoma. Data collection will include tissue and blood samples, which will undergo histologic and genetic analyses. Additionally, relevant clinical history, laboratory results, imaging findings, and gut microbiota profiles will be collected.

To ensure a comprehensive dataset, samples will be collected from eight institutions in Armenia. The project aims to accumulate data from a total of 500 patients, providing a substantial pool for research and analysis.

By establishing the TIR-HCC registry, researchers hope to contribute to the understanding of hepatocellular carcinoma and potentially identify new risk factors associated with the disease. The collected data will aid in advancing knowledge of HCC and guide future strategies for prevention, early detection, and treatment.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Failure to obtain informed consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nikomed Medical Center

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hasmik Ghazinian, MD

Role: PRINCIPAL_INVESTIGATOR

Nikomed Medical Center

Locations

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Nikomed Medical Center

Yerevan, , Armenia

Site Status RECRUITING

Countries

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Armenia

Central Contacts

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Tigran Aghabekyan

Role: CONTACT

99750721 ext. +374

Hasmik Ghazinian, MD

Role: CONTACT

91423802 ext. +374

Facility Contacts

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Hasmik Ghazinian, MD

Role: primary

91423802 ext. +374

References

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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.

Reference Type BACKGROUND
PMID: 33538338 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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https://pubmed.ncbi.nlm.nih.gov/33538338/

Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660

Other Identifiers

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NMC-2301

Identifier Type: -

Identifier Source: org_study_id

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