Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
385 participants
INTERVENTIONAL
2020-01-09
2024-01-09
Brief Summary
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Human papillomavirus (HPV) infection, the leading risk factor for cervical carcinoma, is the most common sexually transmitted infection (STI) with a particularly high prevalence among young women.
In addition, anti-TNF, used in the treatment of RA and SpA, and anti-IL6 receptor, used in that of RA, could have opposite effects on HPV-dependent oncogenesis.
Thus, patients with RA or SpA may have a higher risk than the general population of progression to cervical cytological abnormalities. Evaluation of the chronic carriage of HPV would then be a useful tool in the management of these patients.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Female patients with spondyloarthritis or rheumatoid arthritis
Female patients (18 to 65 years old) with spondyloarthritis or rheumatoid arthritis will undergo HPV screening and a have a close gynecologic follow-up.
Cervical smear
Cervical smear will be obtained using an Ayre spatula and a cervical brush (Cervex-Brush®). HPV test will be performed using the CLART® HPV2 kit (Genomica).This kit enables the detection of 35 genotypes: HPV6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43,44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 68, 70, 71, 72, 73, 81, 82, 83, 84, 85 et 89.
Pregnancy test
Urinary pregnancy test
Sexual activity questionnary
Sexual activity questionnary
Interventions
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Cervical smear
Cervical smear will be obtained using an Ayre spatula and a cervical brush (Cervex-Brush®). HPV test will be performed using the CLART® HPV2 kit (Genomica).This kit enables the detection of 35 genotypes: HPV6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43,44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 68, 70, 71, 72, 73, 81, 82, 83, 84, 85 et 89.
Pregnancy test
Urinary pregnancy test
Sexual activity questionnary
Sexual activity questionnary
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient with rheumatoid arthritis as defined in 2010 ACR/EULAR criteria or with spondyloarthritis as defined in 2009 ASAS criteria
* Patient able to understand the objectives of the study and give documented informed consent
* Patient affiliated to a social security scheme
Exclusion Criteria
* Patient with a history of cervical cancer
* Patient under juridical protection
* Patient unable to provide informed consent due to linguistic or psychic impairment
18 Years
65 Years
FEMALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Fabienne COURY-LUCAS, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France
Bron, , France
Hopital Edouard Herriot - service de rhumatologie
Lyon, , France
Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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69HCL18_0539
Identifier Type: -
Identifier Source: org_study_id
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