HPV Testing as a Prevention of Cervical Dysplasia and Cancer Before Planned Subtotal Hysterectomy

NCT07545525 — Not yet recruiting, 300 participants, General University Hospital, Prague

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HPV Testing as a Prevention of Cervical Dysplasia and Cervical Cancer Before Planned Subtotal Hysterectomy

Registry	NCT07545525
Status	Not yet recruiting
Study type	Observational
Enrollment	300 (Estimated)
Sponsor	General University Hospital, Prague (Other)
Conditions	Cervical Cancer Screening, Human Papilloma Virus (HPV)
Dates	start 2026-04-01 (estimated), primary completion 2028-04-01 (estimated), completion 2029-04-01 (estimated), first posted 2026-04-22, last updated 2026-04-22

-Summary

Patients indicated for subtotal hysterectomy will be tested for High risk HPV and if the result is positive will undergo expert colposcopy and conisation if not indicated otherwise at the time of subtotal hysterectomy

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+Outcome measures

Primary outcomes

Benefit of addition of HPV DNA testing before subtotal hysterectomy [3 years]: Prevalence of HPV positivity in the tested cohort (patients indicated for subtotal hysterectomy). Prevalence of HPV (other than HPV 16 and 18) positivity in the tested cohort (patients indicated for subtotal hysterectomy). Prevalence of abnormal oncological cytology result and correlation to HPV result in the tested cohort (patients indicated for subtotal hysterectomy). Prevalence of cervical intraepithelial leasions in patients who underwent cone biopsy with the subtotal hysterectomy. Prevalence of high grade cervical intraepithelial leasions in patients who underwent cone biopsy with the subtotal hysterectomy. Rate of HPV negativity 6 months after cone biopsy.

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* age over 18
* indication for subtotal hysterectomy
* consent to provide conisation in case the HPV test result is positive

Exclusion Criteria:

* negative HPV test in the last 3 years

+Investigators

Lukáš Dostálek, M.D., Study director, General Universty Hospital in Prague, Czech Republic