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Genetic Factors and Immunological Determinism of Persistent Consequences of Chikungunya (CHIKGENE)

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ClinicalTrials.gov Identifier: NCT03690648
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : October 1, 2018
Sponsor:
Collaborator:
Conservatoire national des Arts et Métiers
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

Brief Summary:

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.


Condition or disease Intervention/treatment
Chikungunya Fever Other: Quality of life survey Genetic: Saliva collection Genetic: Blood collection

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Genetic Factors and Immunological Determinism of Persistent Consequences of Chikungunya Fever: Genome-wide Association Study
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya Fever

Group/Cohort Intervention/treatment
Saliva collection
  • Clinical examination;
  • Quality of life survey;
  • Saliva collection for genetical analysis
Other: Quality of life survey
Administration of scales: SF-12v2, EQ-5D, QCD, DN4, EIMIR, MFIS-5 et EHAD

Genetic: Saliva collection
Collection of 20 ml of saliva with a kit of saliva collection

Saliva and Blood collection
  • Clinical examination;
  • Quality of life survey;
  • Saliva and blood collection for genetical analysis
Other: Quality of life survey
Administration of scales: SF-12v2, EQ-5D, QCD, DN4, EIMIR, MFIS-5 et EHAD

Genetic: Saliva collection
Collection of 20 ml of saliva with a kit of saliva collection

Genetic: Blood collection
Collection of 20 ml of blood with kit of blood collection




Primary Outcome Measures :
  1. 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 ]
    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


Biospecimen Retention:   Samples With DNA
Saliva and blood collection for genetical analysis (GWAS)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subject with a serological status known for Chikungunya virus for the period between March 1st, 2005 and December 31st, 2006 (epidemic period in reunion Island).
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690648


Contacts
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Contact: Patrick GERARDIN, MD +262(0)262359000 ext 8394 patrick.gerardin@chu-reunion.fr
Contact: Samir MEDJANE, PhD samir.medjane@chu-reunion.fr

Locations
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Réunion
CHU de La Réunion Recruiting
Saint-Pierre, Réunion, 97410
Contact: Samir MEDJANE    +262(0)262359750    samir.medjane@chu-reunion.fr   
Principal Investigator: Patrick GERARDIN, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
Conservatoire national des Arts et Métiers

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Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT03690648     History of Changes
Other Study ID Numbers: 2016/CHU/12
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fever
Chikungunya Fever
Body Temperature Changes
Signs and Symptoms
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases