- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03690648
Genetic Factors and Immunological Determinism of Persistent Consequences of Chikungunya (CHIKGENE)
Genetic Factors and Immunological Determinism of Persistent Consequences of Chikungunya Fever: Genome-wide Association Study
Chikungunya virus (CHIKV) infection has become a threat to public health worldwide. Reunion Island, due to the 2005-2006 epidemic, has acquired unique expertise and remains at the forefront of global research on this disease. The idea of genetic determinism of the clinical expression of infectious diseases has been supported by many epidemiological arguments over the past fifty years. The identification of genetic variants, associated with a disease, often allows a better understanding of the molecular mechanisms involved with consequent significant benefits such as the development of specific biomarkers for new preventive (vaccination) and / or therapeutic (drug design) approaches. In the absence of well-documented hypotheses about the genes potentially involved in the occurrence or evolution of a disease, genome-wide association studies (GWAS), whole genome, of nucleotide polymorphisms (SNPs) and the principle of linkage disequilibrium, under the commonly accepted hypothesis that the expression of a common disease is based on a small number of alleles commonly found in the population (frequency of minor allele greater than 1-5%), have become a method of choice, free of hypothesis, to specify the part of heritability of a complex disease and to identify its genetic determinants. Several epidemiological arguments support a significant proportion of genetic determinism in the explanation of the evolutionary pattern of Chikungunya, whose proportion of chronic forms can reach 40-60% in population-based studies conducted in the two years following an epidemic:
- There are few risk factors associated with chronic forms and these appear to be unclear (age, comorbidities with several elements of the metabolic syndrome) or inconsistent (immune burden) in population studies;
- The incidence of severe or atypical forms is rare in the order of 1% of infections;
- In contrast to the acute phase (J1-J21) for which there seems to be a role of the viral load intensity and a consensual pro-inflammatory immune signature according to a recent meta-analysis]; The role of the intensity of the viral load in the pathogenesis of chronic arthralgia (> J90) and their immune signature remain to be determined, the latter being rather nonspecific, according to studies conducted in Reunion, Italy or Singapore.
These elements justify the interest of a GWAS in the Chikungunya to identify new avenues and mechanistic hypotheses likely to explain the chronic arthralgia characteristic of the disease.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Saint-Pierre, Réunion, 97410
- CHU de la Réunion
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- -Subject of the seroprevalence survey or neighbor living in the same neighborhood likely to confirm an exposure status or known;
- Exposure status established by specific IgG serology, collected between March 1st, 2005 and December 31st, 2006;
- Affiliated to a social security scheme;
- Age between 18 and 75 years old;
- Paternal and maternal 1st and 2nd degree ascendants (parents and grandparents) and at least 3 generations of the family present on the island (grandparents born on the island of Réunion);
- Able to spit
Exclusion Criteria:
- Exposure status unknown;
- Absence of social security;
- Age <18 years and> 75 years;
- Physical inability to spit;
- Pregnant women;
- Protected person (tutorship or curatorship).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Saliva collection
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Administration of scales: SF-12v2, EQ-5D, QCD, DN4, EIMIR, MFIS-5 et EHAD
Collection of 20 ml of saliva with a kit of saliva collection
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Saliva and Blood collection
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Administration of scales: SF-12v2, EQ-5D, QCD, DN4, EIMIR, MFIS-5 et EHAD
Collection of 20 ml of saliva with a kit of saliva collection
Collection of 20 ml of blood with kit of blood collection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
identify by a genome-wide association study the genetic factors associated with the evolutionary profile of Chikungunya
Time Frame: through study completion, an average of 1 year
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to determine if certain genetic profiles may be predictive of progression to asymptomatic or acute disease, or to the chronic character of the manifestations of the disease
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through study completion, an average of 1 year
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/CHU/12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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