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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06227468
Other study ID # ALTP.2023.001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 12, 2023
Est. completion date August 31, 2026

Study information

Verified date January 2024
Source Athens LifeTech Park
Contact Efi Giannopoulou
Phone +306974784009
Email egiannopoulou@lifetechpark.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12000
Est. completion date August 31, 2026
Est. primary completion date May 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
Greece Department of Infectious Diseases, 2nd Department of Internal Medicine, University General Hospital of Alexandroupolis Alexandroupolis
Greece Department of Respiratory Medicine, University General Hospital of Alexandroupolis Alexandroupolis Thrace
Greece 2nd Propaedeutic Department of Internal Medicine, Attikon University General Hospital Chaidari Attiki
Greece Department of Cardiology, University General Hospital of Heraklion Heraklion
Greece Department of Rheumatology, University Hospital of Heraklion Heraklion
Greece Department of Respiratory, University Hospital of Ioannina Ioannina
Greece Department of Haematology, University General Hospital of Larissa Larissa
Greece 2nd Department of Neurology, AHEPA University Hospital Thessaloníki Thessaloniki

Sponsors (2)

Lead Sponsor Collaborator
Athens LifeTech Park Galatea.Bio

Country where clinical trial is conducted

Greece, 

References & Publications (3)

Dendrou CA, Petersen J, Rossjohn J, Fugger L. HLA variation and disease. Nat Rev Immunol. 2018 May;18(5):325-339. doi: 10.1038/nri.2017.143. Epub 2018 Jan 2. — View Citation

Sanchez-Mazas A, Nunes JM, Middleton D, Sauter J, Buhler S, McCabe A, Hofmann J, Baier DM, Schmidt AH, Nicoloso G, Andreani M, Grubic Z, Tiercy JM, Fleischhauer K. Common and well-documented HLA alleles over all of Europe and within European sub-regions: A catalogue from the European Federation for Immunogenetics. HLA. 2017 Feb;89(2):104-113. doi: 10.1111/tan.12956. — View Citation

Zhou Y, Krebs K, Milani L, Lauschke VM. Global Frequencies of Clinically Important HLA Alleles and Their Implications For the Cost-Effectiveness of Preemptive Pharmacogenetic Testing. Clin Pharmacol Ther. 2021 Jan;109(1):160-174. doi: 10.1002/cpt.1944. Epub 2020 Jul 26. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Allele frequency of HLA-alleles at the Greek population level To assess the HLA allelic diversity of Greek population 36th month
Secondary Prevalence of selected HLA-related diseases in the Greek population Characterization of the allelic and haplotypic HLA frequency distribution in the Greek population and comparison with global HLA databases. 36th month
Secondary Relative Risk (Risk Ratio (RR) or Odds Ratio (OR)) of HLA markers on diseases of interest Evaluation of the association between HLA alleles and/or haplotypes, and selected diseases 36th month
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