HPV Infection Clinical Trial
Official title:
Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases
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).
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04098744 -
Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
|
Phase 2 | |
| Completed |
NCT04083196 -
A Randomized, Blinded, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Preliminary Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years
|
Phase 1 | |
| Completed |
NCT04191967 -
Thermocoagulation for Treatment of Precancerous Cervical Lesions
|
N/A | |
| Withdrawn |
NCT04430907 -
HPV Vaccine in Postpartum Women
|
||
| Recruiting |
NCT02593968 -
Yallaferon in Chinese Population
|
Phase 2 | |
| Completed |
NCT04711265 -
Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
|
||
| Completed |
NCT02263378 -
A New Supplement for the Immune Response to HPV Infection
|
N/A | |
| Completed |
NCT05234112 -
Prevention and Screening Towards Elimination of Cervical Cancer
|
N/A | |
| Completed |
NCT04590521 -
HPV Vaccine Immunity in High-risk Women
|
Phase 4 | |
| Recruiting |
NCT05829629 -
Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women
|
Phase 1 | |
| Recruiting |
NCT06052033 -
Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection
|
N/A | |
| Recruiting |
NCT05051852 -
HPV Viral Load in Predicting the Prognosis of LSIL
|
||
| Completed |
NCT04155294 -
Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention in Women Living With HIV
|
||
| Active, not recruiting |
NCT06452004 -
Validation of Artificial Intelligence as Decision Support System in VIA (PRESCRIP-TEC)
|
N/A | |
| Completed |
NCT06177236 -
Clinic or Self-Sampling for Cervical Cancer Screening
|
N/A | |
| Active, not recruiting |
NCT04794660 -
The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"
|
Phase 3 | |
| Recruiting |
NCT05509413 -
DEFLAGYN® Vaginal Gel and Spontaneous Remission and Regression of Unclear Cervical Smears and HPV High-risk Infections
|
N/A | |
| Recruiting |
NCT06137950 -
Interferon Alpha Therapy for Cervical CINI and HPV Infection
|
Phase 1 | |
| Recruiting |
NCT04171505 -
Retrospective Cohort Study of the Effectiveness of the Prophylactic Vaccine Against the Human Papilloma Virus in the Prevention of Recurrence in Women Who Have Received an Excisional Therapy by HSIL / CIN.
|
||
| Active, not recruiting |
NCT05524025 -
The SPOT-HPV Study
|