NCT06302725Befejeződött
Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 7.
Rövid összefoglaló (regiszter, angolul)
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).
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 278 (tényleges)
- Első benyújtás
- 2024. márc. 4.
- Kezdés
- 2024. márc. 1.
- Elsődleges befejezés
- 2026. jún. 16.
- Fő szponzor
- Assistance Publique - Hôpitaux de Paris
- Betegségek
- Méhnyakrák
- NCT-szám
- NCT06302725
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 278
- 2024. márc. 1. és az elsődleges befejezés (2026. jún. 16.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Más betegség
- History of colpohysterectomy
Egyéb
- Prospective and retrospective patient
- Patient under legal protection, guardianship, or trusteeship
- Not affiliated with a social security scheme (general or CMU)
- Absence of informed and written consent
Kiket keres a vizsgálat
- Prospective and retrospective patient
- 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
- Not up to date with gynecological follow-up (i.e., Pap smear more than one year old or undatable) (for retrospective patients: at the time of initial screening)
- Retrospective patient
- Patient who underwent Pap smear screening less than one year before the start of the study
Életkor a regiszterben: 30 év – 65 év · Nem: csak nők · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Service de Médecine Interne - Hôpital Bichat Claude Bernard | Paris | Franciaország | Ismeretlen állapot |
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