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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2026
  • participants needed
    12000
  • sponsor
    Athens LifeTech Park
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Updated on 29 January 2024
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Accepts healthy volunteers

Summary

The aim of GENESIS clinical study is to map the HLA genomic region in the Greek population and evaluate possible correlations with selected underlying diseases.

Description

The GENESIS study is a multicenter, prospective, non-interventional, clinical study with a target of 12,000 subjects and an anticipated total duration of 36 months. The aim of study GENESIS is to provide a pilot map of HLA genetic variation in the Greek population in order to be used in medical research and for possible clinical applications (evaluation of possible correlations with selected underlying diseases). During the study, each subject will conduct one visit to the participating cite, in which they will provide:

  1. Demographic information [i.e. date of birth, gender, race, ancestry (including information about the subject's grandparents' birthplace), height, weight],
  2. Other information about smoking/vaping, alcohol consumption, arterial blood pressure, diagnosed diseases (if any), current treatments (if any), and
  3. Recent (up to 12 months prior to sample collection) results if/when are available from clinical lab tests such as blood count (Hct, Hb, RBC, WBC, PLT count), including a metabolic panel, liver enzymes and biochemical parameters (Glu, HbA1c, TC, TG, LDL-C, HDL-C, ALT, AST, ALP, γGT, bilirubin, LDH, insulin, C-peptide).

Upon completion of the data registry, two buccal swabs will be collected per subject and they will be stored at ALTP premises until their shipment to Galatea.Bio. All buccal swab samples will be subjected to genetic material (DNA) extraction. The DNA samples will be further proceeded for HLA genotyping analysis. A follow up analysis will be performed in selected DNA samples via full low-pass whole genome sequencing (LP-WGS), which aims to further investigate the association between the HLA region and autoimmune diseases.

Upon completion of the analysis, an individualized ancestry report will be securely made available to all study subjects which they can access, as and if they elect to.

Details
Condition Healthy, Respiratory Disease, Chronic Renal Failure, Cardiovascular Diseases, Metabolic Disease, Psychiatric Disorder, Neurologic Disorder, Gastrointestinal Diseases, Haematologic Disease, Rheumatologic Disease
Age 18years or above
Clinical Study IdentifierNCT06227468
SponsorAthens LifeTech Park
Last Modified on29 January 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

The study will include adult subjects (age ≥ 18) that
possess a Greek social security number and are visiting hospitals/clinics, and/or other private laboratory institutions (incl. clinics and health care groups) as part of standard clinical practice in Greece
are willing and able to provide written informed consent to participate in the study according to the study protocol

Exclusion Criteria

Subjects not able to provide written informed consent (e.g. ICU patients, mental illness patients, lack of legal capacity)
Subjects who have had an allogeneic (non-self-donor)
bone marrow transplant
stem cell transplant
blood transfusion less than two weeks prior to buccal swab sample collection
liver transplant
Subjects who participated in an interventional clinical trial in the past that
according to the subject's physician opinion might have had an impact on their
HLA genome
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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