HealthyGENESISNCT06227468
A Clinical Study to Map the HLA Genomic Region in the Greek Population
An observational study of Healthy and Respiratory Disease, run by Athens LifeTech Park at 8 sites in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Respiratory Disease, Chronic Renal Failure
- How many people
- 12,000 participants
- Where
- 8 sitesGreece
- Study dates
- 12 Dec 2023to 31 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Greece8 sites, 8 recruiting
- Recruiting
Department of Respiratory Medicine, University General Hospital of Alexandroupolis
Alexandroupoli, Thrace, 68100
Steiropoulos, Professor
- Recruiting
Department of Infectious Diseases, 2nd Department of Internal Medicine, University General Hospital of Alexandroupolis
Alexandroupoli, 68100
Papazoglou, Professor
- Not yet recruiting
2nd Propaedeutic Department of Internal Medicine, Attikon University General Hospital
Chaïdári, Attica, 12462
Lambadiari, Professor
- Not yet recruiting
Department of Cardiology, University General Hospital of Heraklion
Heraklion, 71110
Μarketou, Professor
- Not yet recruiting
Department of Rheumatology, University Hospital of Heraklion
Heraklion, 71110
Sidiropoulos, Professor
- Recruiting
Department of Respiratory, University Hospital of Ioannina
Ioannina, 45500
Kostikas, Professor
- Not yet recruiting
Department of Haematology, University General Hospital of Larissa
Larissa, 41110
Vasilopoulos, Professor
- Not yet recruiting
2nd Department of Neurology, AHEPA University Hospital
Thessaloniki, Thessaloniki, 54636
Grigoriadis, Professor
About this study
Official title: A Clinical Study to Map the HLA GENomic Region and Its potEntial aSsocIation With Selected diSeases in the Greek Population
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.
Read the detailed 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:
- Demographic information [i.e. date of birth, gender, race, ancestry (including information about the subject's grandparents' birthplace), height, weight],
- Other information about smoking/vaping, alcohol consumption, arterial blood pressure, diagnosed diseases (if any), current treatments (if any), and
- 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.
- Conditions
- Healthy, Respiratory Disease, Chronic Renal Failure, Cardiovascular Diseases, Metabolic Disease, Psychiatric Disorder
- Medical subject headings
- Respiration Disorders, Kidney Failure, Chronic, Cardiovascular Diseases, Metabolic Diseases, Mental Disorders, Nervous System Diseases, Gastrointestinal Diseases, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Greek population | The enrolled subjects will be managed as a single group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allele frequency of HLA-alleles at the Greek population level
To assess the HLA allelic diversity of Greek population
Measured: 36th month
Secondary outcomes (2)
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.
Measured: 36th month
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
Measured: 36th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start12 Dec 2023
- Primary completion31 May 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Athens LifeTech Park
- Sponsor type
- University, hospital or other
- Collaborators
- Galatea.Bio
- Responsible party
- Sponsor
- Investigators
- Efi Giannopoulou, Study director, Athens LifeTech Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227468
- Sponsor's protocol ID
- ALTP.2023.001
- Acronym
- GENESIS
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan for sharing IPD at this stage
Publications
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.
PubMed 28102034Dendrou 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.
PubMed 29292391Zhou 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.
PubMed 32535895
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Map the HLA GENomic Region and Its potEntial aSsocIation With Selected diSeases in the Greek Population
- ClinicalTrials.gov ID
- NCT06227468
- Acronym / sponsor ID
- GENESIS / ALTP.2023.001
- Conditions
- Healthy, Respiratory Disease, Chronic Renal Failure, Cardiovascular Diseases, Metabolic Disease, Psychiatric Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Athens LifeTech ParkUniversity, hospital or other
- Collaborators
- Galatea.Bio
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 26 Jan 2024 (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 aim of GENESIS clinical study is to map the HLA genomic region in the Greek population and evaluate possible correlations with selected underlying diseases.
Detailed 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:
- Demographic information [i.e. date of birth, gender, race, ancestry (including information about the subject's grandparents' birthplace), height, weight],
- Other information about smoking/vaping, alcohol consumption, arterial blood pressure, diagnosed diseases (if any), current treatments (if any), and
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Greek population | – | –The enrolled subjects will be managed as a single group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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):
- 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.
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
Allele frequency of HLA-alleles at the Greek population level
Time frame: 36th month
To assess the HLA allelic diversity of Greek population
2 secondary outcomes
Prevalence of selected HLA-related diseases in the Greek population
Time frame: 36th month
Relative Risk (Risk Ratio (RR) or Odds Ratio (OR)) of HLA markers on diseases of interest
Time frame: 36th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Background: PubMed 28102034Sanchez-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.
- Background: PubMed 29292391Dendrou 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.
- Background: PubMed 32535895Zhou 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.
- Individual participant dataSharing planned: No. No plan for sharing IPD at this stage
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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. This study is not recruiting at the moment.
Efi Giannopoulou study director
Athens LifeTech Park
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Respiratory Disease, run by Athens LifeTech Park at 8 sites in Greece.
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 7 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: status not confirmed, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Efi Giannopoulou (+306974784009, egiannopoulou@lifetechpark.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allele frequency of HLA-alleles at the Greek population level (time frame: 36th month). 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 NCT06227468, which also lists 3 linked publications.
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 26 Jan 2024.