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

April 21, 2026 updated by: Tomáš Fučík, General University Hospital, Prague

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

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

Study Overview

Status

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Benefit of addition of HPV DNA testing before subtotal hysterectomy
Time Frame: 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.

3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Lukáš Dostálek, M.D., General Universty Hospital in Prague, Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 032026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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