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Trial Title:
Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases
NCT ID:
NCT06302725
Condition:
HPV Infection
Systemic Disease
Conditions: Official terms:
Infections
Communicable Diseases
Papillomavirus Infections
Conditions: Keywords:
HPV
systemic disease
cervical cancer screening
vaginal self sampling
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Vaginal self sampling detecting HPV
Description:
IMIDs patients who are not up to date with CCS be included into the study to perform a
vaginal self-screening (VSS) A positive VSS will be confirmed by a standard HPV test and
management of the results of standard HPV test or VSS will be performed as planned
following HAS guidelines. For women with a positive VSS, follow-up results (HPV test and
cytology, biopsy, etc.) will be collected according to the usual procedures of the
screening facility and in accordance with the recommendations of the Health authorities
Arm group label:
Vaginal self sampling detecting HPV
Summary:
Main objective: -To determine Human Papilloma Virus (HPV) prevalence in patients with
immune-mediated inflammatory diseases (IMID) using vaginal self-sampling (VSS), one year
after VSS was proposed Primary endpoint: - To determine the prevalence of HPV infection
(yes/no) after VSS proposal Secondary objectives: - To describe the HPV typology and the
rate of co-infection (with several high-risk HPV (HR-HPV)) in this population - To
describe the factors associated with the presence of HPV infection - To determine the
rate of HPV clearance after one year, during the second screening at 12 months- To
determine the percentage of pre-cancerous cervical lesions and cervical cancer in the
event of subsequent cervical smear - To determine the factors associated with persistence
(or non-clearance ) of HPV infection - To determine the factors associated with the
presence of pre-cancerous and cancerous cervical lesions - To determine the
characteristics, tolerance and acceptability of VSS - To determine the rate of cervical
cancer screening carried out following French Health Authorities guidelines -To determine
the HPV vaccination coverage Secondary endpoints: 1/ HPV typology and presence of
co-infection (Yes/No, type) or HPV multi-infection (more than 2 HPV, Yes/No) identified
on samples at inclusion and at 1 year. 2/ Explanatory variables: demographic, clinical,
biological factors and treatments (corticoids, immunosuppressive treatments); variable to
be explained: presence of HPV infection during follow-up. 3/ Characteristics,
acceptability, obstacles and tolerance of VPA reported by self-questionnaire (including
procedure failures, bleeding and pain). 4/ Up-to-date cervical cancer screening rate in
accordance with HAS recommendations at 12 months post-procedure. 5/ Proportion of
cervical cytological abnormalities and cervical cancer authenticated on cervico-vaginal
smear, if performed (histological confirmation if available) during follow-up. 6/
Explanatory variables: demographic, clinical, biological factors and treatments
(corticoids, immunosuppressants; variable to be explained: presence of cervical
precancerous lesions and cervical cancer, authenticated on cervico-vaginal smear, if
performed (histological confirmation if available) during follow-up. 7/ HPV vaccination
coverage rate (measured on initial self-questionnaire) 8/ Prevalence of HR-HPV(s) at
second screening at one year, in the case of initial positivity (Persistence of HPV
infection (Yes/No). 9/ Explanatory variables: demographic, clinical, biological factors
and treatments (corticoids, immunosuppressive treatments); variable to be explained:
persistence of cervical HPV infection at one year (in the case of initial positivity).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Women aged 30 to 65 years old
- presenting with MSIA, MSIA includes Systemic lupus erythematosus Sjögren's syndrome
Systemic scleroderma Mixed connective tissue disease Inflammatory myositis Systemic
sarcoidosis Systemic vasculitis Behçet's disease Adult-onset Still's disease
IgG4-related disease Autoimmune cytopenia (autoimmune hemolytic anemia, immune
thrombocytopenic purpura, Evans syndrome) Susac syndrome
- Followed in the internal medicine department of Bichat Hospital, Paris
- At least 1 scheduled visit between December 2023 and December 2025
- Not up to date with gynecological follow-up (i.e., cervical cancer screening more
than one year old or undatable)
Exclusion Criteria:
- Patient under legal protection, guardianship, or trusteeship
- History of colpohysterectomy
- Not affiliated with a social security scheme (general or CMU)
- Absence of informed and written consent
Gender:
Female
Minimum age:
30 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Service de Médecine Interne - Hôpital Bichat Claude Bernard
Address:
City:
Paris
Zip:
75018
Country:
France
Status:
Recruiting
Contact:
Last name:
Tiphaine Goulenok, MD
Phone:
00 33 1 40 25 72 89
Email:
tiphaine.goulenok@aphp.fr
Start date:
March 1, 2024
Completion date:
March 2027
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06302725