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

NCT06227468 | Recruiting

• 1 other identifier: ALTP.2023.001
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Healthy; Respiratory Disease; Chronic Renal Failure; Cardiovascular Diseases; Metabolic Disease; Psychiatric Disorder; Neurologic Disorder; Gastrointestinal Diseases; Haematologic Disease; Rheumatologic Disease

Outcome Measures

Primary Outcomes (1)

• Allele frequency of HLA-alleles at the Greek population level

  To assess the HLA allelic diversity of Greek population

  36th month

Secondary Outcomes (2)

• Prevalence of selected HLA-related diseases in the Greek population

  36th month

• Relative Risk (Risk Ratio (RR) or Odds Ratio (OR)) of HLA markers on diseases of interest

  36th month

Study Arms (1)

Greek population

The enrolled subjects will be managed as a single group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will recruit and enroll eligible subjects possessing a Greek social security number, who are visiting hospitals/clinics and/or other private laboratory practices (incl. clinics and health care groups) as part of standard clinical practice.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Athens LifeTech Park: lead
• Galatea.Bio: collaborator

Study Sites (8)

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

Chaïdári, Attica, 12462, Greece

NOT YET RECRUITING

2nd Department of Neurology, AHEPA University Hospital

Thessaloniki, Thessaloniki, 54636, Greece

NOT YET RECRUITING

Department of Respiratory Medicine, University General Hospital of Alexandroupolis

Alexandroupoli, Thrace, 68100, Greece

RECRUITING

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

Alexandroupoli, 68100, Greece

RECRUITING

Department of Cardiology, University General Hospital of Heraklion

Heraklion, 71110, Greece

NOT YET RECRUITING

Department of Rheumatology, University Hospital of Heraklion

Heraklion, 71110, Greece

NOT YET RECRUITING

Department of Respiratory, University Hospital of Ioannina

Ioannina, 45500, Greece

RECRUITING

Department of Haematology, University General Hospital of Larissa

Larissa, 41110, Greece

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 28102034 BACKGROUND

• 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.

  PMID: 29292391 BACKGROUND

• 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.

  PMID: 32535895 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Two buccal swabs per subject

MeSH Terms

Conditions

Respiration Disorders; Kidney Failure, Chronic; Cardiovascular Diseases; Metabolic Diseases; Mental Disorders; Nervous System Diseases; Gastrointestinal Diseases; Hematologic Diseases; Collagen Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Digestive System Diseases; Hemic and Lymphatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Efi Giannopoulou

  Athens LifeTech Park

  STUDY DIRECTOR

Central Study Contacts

Efi Giannopoulou

CONTACT

+306974784009; egiannopoulou@lifetechpark.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 26, 2024
• Study Start: December 12, 2023
• Primary Completion: May 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (8)