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

NCT07545525 | Not Yet Recruiting DMC

• 1 other identifier: 032026
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Cervical Cancer Screening; Human Papilloma Virus (HPV)

Outcome Measures

Primary Outcomes (1)

• Benefit of addition of HPV DNA testing before subtotal hysterectomy

  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.

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women over 18 years old indicated for subtotal hysterectomy surgery mostly due to pelvic organ prolapse

You may qualify if:

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

You may not qualify if:

• negative HPV test in the last 3 years

Sponsors & Collaborators

• General University Hospital, Prague: lead

Study Officials

• Lukáš Dostálek, M.D.

  General Universty Hospital in Prague, Czech Republic

  STUDY DIRECTOR

Central Study Contacts

Tomas Fučík, M.D.

CONTACT

724188696; fuciktomas93@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tomas Fucik M.D.

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04