Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06227468

A Clinical Study to Map the HLA Genomic Region and Its Potential Association With Selected Diseases in the Greek Population

Led by Athens LifeTech Park · Updated on 2024-01-26

12000

Participants Needed

8

Research Sites

65 weeks

Total Duration

On this page

Sponsors

A

Athens LifeTech Park

Lead Sponsor

G

Galatea.Bio

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.

CONDITIONS

Brief Title

A Clinical Study to Map the HLA Genomic Region in the Greek Population

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Possess a Greek social security number
  • Visiting hospitals, clinics, or private labs as part of standard clinical practice in Greece
  • Willing and able to provide written informed consent to participate according to the study protocol
Not Eligible

You will not qualify if you...

  • Unable to provide written informed consent (e.g., ICU patients, mental illness, lack of legal capacity)
  • History of allogeneic bone marrow transplant
  • History of stem cell transplant
  • Blood transfusion within two weeks prior to buccal swab collection
  • History of liver transplant
  • Participation in an interventional clinical trial that might have impacted the HLA genome according to physician opinion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 1 visit

Participants provide demographic information, health history, and recent clinical lab test results, and have buccal swab samples collected for genetic analysis.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 36 months

Participants' genetic data are analyzed and an individualized ancestry report is made available to them if they choose to access it.

Trial Site Locations

Total: 8 locations

1

2nd Propaedeutic Department of Internal Medicine, Attikon University General Hospital

Chaïdári, Attica, Greece, 12462

Not Yet Recruiting

2

2nd Department of Neurology, AHEPA University Hospital

Thessaloniki, Thessaloniki, Greece, 54636

Not Yet Recruiting

3

Department of Respiratory Medicine, University General Hospital of Alexandroupolis

Alexandroupoli, Thrace, Greece, 68100

Actively Recruiting

4

Department of Infectious Diseases, 2nd Department of Internal Medicine, University General Hospital of Alexandroupolis

Alexandroupoli, Greece, 68100

Actively Recruiting

5

Department of Cardiology, University General Hospital of Heraklion

Heraklion, Greece, 71110

Not Yet Recruiting

6

Department of Rheumatology, University Hospital of Heraklion

Heraklion, Greece, 71110

Not Yet Recruiting

7

Department of Respiratory, University Hospital of Ioannina

Ioannina, Greece, 45500

Actively Recruiting

8

Department of Haematology, University General Hospital of Larissa

Larissa, Greece, 41110

Not Yet Recruiting

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Research Team

E

Efi Giannopoulou

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Common and well-documented HLA alleles over all of Europe and within European sub-regions: A catalogue from the European Federation for Immunogenetics.

A Sanchez-Mazas, J M Nunes, D Middleton...

https://pubmed.ncbi.nlm.nih.gov/28102034

Global Frequencies of Clinically Important HLA Alleles and Their Implications For the Cost-Effectiveness of Preemptive Pharmacogenetic Testing.

Yitian Zhou, Kristi Krebs, Lili Milani...

https://pubmed.ncbi.nlm.nih.gov/32535895