NCT07343336

Brief Summary

The aim of this research is to characterise the genetic and molecular landscape of gout, inflammation and metabolic diseases, as well as the associated molecular, anthropomorphic and pathological characteristics.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,750

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Sep 2025

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Sep 2025Sep 2027

Study Start

First participant enrolled

September 2, 2025

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

October 1, 2025

Last Update Submit

January 6, 2026

Conditions

Keywords

Gout diseasemetabolic diseaseinflammation

Outcome Measures

Primary Outcomes (1)

  • GWAS-identified associations between population-enriched genetic variants and health-related traits

    Effect estimates (odds ratios or beta coefficients) for statistically significant associations between population-enriched genetic variants and predefined health-related traits identified through GWAS.

    12 month

Secondary Outcomes (9)

  • Multiple correlation between gout, hyperuricemia, type 2 diabetes and obesity

    12 month

  • Incidence rate of gout or HU in French Polynesia between 2021 and 2025

    4 years

  • Proportion of each type of urate-lowering therapy prescribed annually between 2019 and 2025

    4 years

  • Incidence of major adverse cardiovascular events (MACE) in patients with gout, diabetes, or obesity

    12 month

  • Determinants of progression from asymptomatic hyperuricemia (in 2021) to gout (in 2025)

    4 years

  • +4 more secondary outcomes

Study Arms (3)

General Population Group

Patients aged between 18 and 75 years old who did not take part in the TOPATA study in 2021 and who visit their general practitioner for a consultation (for whatever reason)

Other: Epidemiological studyDiagnostic Test: Blood and urine tests

Gout Group

Patients aged between 18 and 75 years old who are treated at the rheumatology clinic of the Taaone Hospital Centre (CHT) in Papeete by Dr Baptiste Gérard. * There is a tophaceous gout subgroup: patients with tophaceous gout. * And a gout attack subgroup: patients presenting with a gout crisis.

Other: Epidemiological studyDiagnostic Test: Blood and urine tests

Follow-up group 2021

Patients aged between 18 and 75 years old who were included in the TOPATA study in 2021 and for whom genetic and biological samples during the 2021 study were taken. Patients must have had hyperuricaemia without signs of gout OR without hyperuricaemia or gout at the time of inclusion in the 2021 TOPATA study.

Other: Epidemiological studyDiagnostic Test: Blood and urine tests

Interventions

Collection of sociodemographic data, collection of treatment data, standard and clinical ophthalmological examination, physical and biological measurements, clinical characteristics specific to chronic and metabolic diseases, questionnaires (gout questionnaire, health assessment questionnaire (HAQ-II), EuroQol (EQ)-5D-5L, joint pain, state of health, diet and physical activity, access to care, addictions, sleep quality, pain scale (EVA), personal and family history) will be performed.

Follow-up group 2021General Population GroupGout Group
Blood and urine testsDIAGNOSTIC_TEST

Collection of blood and urine samples for genetic, biochemical, omics, and biobank analyses, in order to characterize cardiometabolic health markers will be performed.

Follow-up group 2021General Population GroupGout Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General population group: Participants will be recruited by general practitioners or study nurses during consultations in community-based practices. The objective is to include a representative general population sample, with no specific reason for consultation required or excluded. Gout group: Patients will be recruited at the Rheumatology Clinic of the Taaone Hospital Center (CHT) in Papeete when presenting with gout symptoms, either tophaceous gout or an acute flare within the previous 48 hours. 2021 follow-up group: Participants from the TOPATA study conducted in 2021 will be recontacted by telephone to assess willingness to participate, followed by an in-person inclusion visit. Only individuals currently living in Tahiti will be contacted. Nurses will be responsible for recruitment, biological sample collection, physical measurements, and questionnaire administration.

You may qualify if:

  • All participants:
  • Age between 18 and 75 years old inclusive
  • Signature of informed consent
  • Fasting for the collection of biological samples
  • Declared Polynesian ancestry
  • Affiliated to a social security scheme
  • General population group :
  • Not having participated to the 2021 TOPATA study
  • Visiting a general practitioner (for whatever reason)
  • Gout Group :
  • Managed at the rheumatology clinic of the Taaone Hospital Centre (CHT) in Papeete by Dr Baptiste Gérard.
  • Tophaceous gout sub-group:
  • Present with tophaceous gout.
  • Gout crisis subgroup:
  • Be within 48 hours of the onset of a gout attack
  • +3 more criteria

You may not qualify if:

  • All participants :
  • Refusal or inability to understand or give consent
  • Physical inability to follow and respect the protocol
  • st degree relative\*,
  • Person under guardianship or trusteeship
  • Pregnant or breast-feeding woman
  • \* If several relatives from the same household are eligible to participate, only one person may be included in the study. The choice is left to the discretion of the investigator or the first person met. However, both members of a couple (e.g. husband and wife) may participate.
  • General population group :
  • Unable to return for sampling if required.
  • Gout group :
  • Person wearing a knee prosthesis
  • People suffering from other inflammatory rheumatic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Medical Office Dr Antoine Scuiller

Faa'a, 98702, French Polynesia

RECRUITING

Medical Office Dr Cedric Gueguen

Papeete, 98713, French Polynesia

RECRUITING

Medical Office Dr Voradeth Nouanesengsy

Papeete, 98714, French Polynesia

RECRUITING

CH de Polynesie Française Papeete

Pirae, 98716, French Polynesia

NOT YET RECRUITING

Medical Office Dr Nanethida Nouanesengsy

Pirae, 98716, French Polynesia

RECRUITING

Medical Office Dr Raphael Habib

Pirae, 98716, French Polynesia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample, urine sample, synovial fluid

MeSH Terms

Conditions

Metabolic DiseasesInflammation

Interventions

Epidemiologic StudiesBlood Specimen CollectionUrinalysis

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeClinical Chemistry TestsDiagnostic Techniques, Urological

Study Officials

  • Tristan Pascart, Professor

    GHICL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

October 1, 2025

First Posted

January 15, 2026

Study Start

September 2, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations