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Intraoperative HPV Testing Evaluation

NCT04190472 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1553

Last updated 2020-05-01

No results posted yet for this study

Summary

High-grade intraepithelial lesion/cervical intraepithelial neoplasia grade 2-3 is a premalignant cervical lesion caused by persistent high-risk human papillomavirus infection. Human papillomavirus test is a very sensitive risk marker of cervical cancer and it has been incorporated in the follow-up after high-grade intraepithelial lesion treatment. Papillomavirus test performed intraoperatively could be a beneficial approach to anticipate treatment failure, allow for early management and consequently a reduction in costs. The aim of this study is to evaluate if the IOP-HPV test has non-inferior diagnostic utility of HSIL/CIN2-3 recurrence at 24 months as the HPV test performed 6 months after treatment.

Conditions

  • HSIL, High Grade Squamous Intraepithelial Lesions
  • Recurrence

Interventions

DIAGNOSTIC_TEST

IOP HPV test

Immediately after the LEEP, a cervical sample was taken for the IOP-HPV test

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Cristina Centeno Mediavilla, PhD · Hospital Universitari Vall Hebron

  • Melissa Bradbury Lobato, PhD · Hospital Vall d'Hebron

  • Antonio Gil Moreno, PhD · Hospital Vall d'Hebron

  • Jordi Rabasa Antonijuan, PhD · Hospital Vall d'Hebron

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2022-06-01
Completion
2024-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04190472 on ClinicalTrials.gov