Hepatocellular CarcinomaTIR-HCCNCT05935189
Establishment of a Tissue Registry for Hepatocellular Carcinoma Specimens
An observational study of Hepatocellular Carcinoma, run by Nikomed Medical Center at 1 site in Armenia.
Trial 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. provide a mechanism to store the information about subjects with hepatocellular carcinoma 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 500 participants
- Where
- 1 siteArmenia
- Study dates
- 1 Jul 2023to 1 Jul 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population is composed of individuals from Armenian descent who have a biopsy-confirmed diagnosis of hepatocellular carcinoma.
Who may be able to join
- Patients with biopsy-confirmed diagnosis of HCC
- Armenian descent
- Having given their signed Informed consent
Who cannot join
- Failure to obtain informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Armenia1 site, 1 recruiting
- Recruiting
Nikomed Medical Center
Yerevan
Hasmik Ghazinian, MD, 91423802 ext. +374, ghazinian@gmail.com
About this study
Official title: Establishment of a Tissue Registry for Hepatocellular Carcinoma Specimens for Genetic and Histologic Research
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:
- provide a mechanism to store the information about subjects with hepatocellular carcinoma
- use of tissue samples for translational/further research purposes
Read the detailed description
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
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Nikomed Medical Center
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Hasmik Ghazinian, MD, Principal investigator, Nikomed Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935189
- Sponsor's protocol ID
- NMC-2301
- Acronym
- TIR-HCC
- Status last verified
- Jun 2023
- First submitted
- 20 Jun 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33538338
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Tissue Registry for Hepatocellular Carcinoma Specimens for Genetic and Histologic Research
- ClinicalTrials.gov ID
- NCT05935189
- Acronym / sponsor ID
- TIR-HCC / NMC-2301
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Nikomed Medical CenterResearch network
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- provide a mechanism to store the information about subjects with hepatocellular carcinoma
- use of tissue samples for translational/further research purposes
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is composed of individuals from Armenian descent who have a biopsy-confirmed diagnosis of hepatocellular carcinoma.
Key inclusion criteria (3 listed)
- Patients with biopsy-confirmed diagnosis of HCC
- Armenian descent
- Having given their signed Informed consent
Key exclusion criteria (1 listed)
- Failure to obtain informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Creation of a registry
Time frame: 5 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Background: PubMed 33538338Sung 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.
- 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.21660Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hasmik Ghazinian, MD principal investigator
Nikomed Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Nikomed Medical Center at 1 site in Armenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tigran Aghabekyan (99750721 ext. +374, tigran1999@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of a registry (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05935189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.