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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT01754311 |
Date of registration:
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14/12/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Influence of IL28B Genetic Variation on the Phenotype Infection of HTLV-1
HAMIL28B |
Scientific title:
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Influence of IL28B Genetic Variation on the Phenotype Infection of HTLV-1 |
Date of first enrolment:
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May 13, 2013 |
Target sample size:
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155 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01754311 |
Study type:
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Observational |
Study design:
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Phase:
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Countries of recruitment
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Martinique
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Contacts
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Name:
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Stephane Olindo, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital of Fort de France |
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Key inclusion & exclusion criteria
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Inclusion Criteria :
HAM/TSP Patient:
- Age over 18 years
- Whose HAM/TSP was diagnosed on the criteria of Belem (De Castro-Costa et al., 2006)
- Follow regular consultation of Neurology of the University Hospital of Fort-de-France,
- Affiliate a system of social security (or entitled Beneficiary)
- Having agreed to participate in research by signing the consent form.
HTLV-1 asymptomatic patient:
- Age over 18 years
- Follow regular consultation of Neurology of the University Hospital of Fort-de-France,
- Do not show clinical signs of neurological impairment (a pyramidal syndrome with
functional impairment clinic, genito-sphincter, motor deficits suggestive of
polymyositis belts)
- Affiliate a system of social security (or entitled Beneficiary)
- Having agreed to participate in research by signing the consent form.
Blood donors:
- Respecting the eligibility criteria for blood donation
- Affiliated with the social security system (or entitled Beneficiary)
- Having agreed to participate in research by signing the consent form
- Serology HTLV-1 negative at the time of blood donation
Exclusion Criteria :
HAM/TSP Patient:
- Featuring an intricate polypathology may cast doubt on the responsibility of HTLV-1 in
neurological symptoms,
- Infected with HIV or HBV or HCV
- Not affiliated to a social security (or entitled beneficiary)
- Do not sign the form for obtaining consent.
HTLV-1 asymptomatic patient:
- Infected with HIV or HBV or HCV
- Not affiliated to a social security (or entitled beneficiary)
- Do not sign the form obtaining informed consent.
Blood donors:
- Do not meet the eligibility criteria for blood donation
- Not affiliated to a social security (or entitled beneficiary)
- Do not sign the form obtaining informed consent
- Serology HTLV-1 positive or doubtful
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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HTLV-I Infections
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Primary Outcome(s)
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Presence of CT or TT allele for each participant
[Time Frame: 30 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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