MedTrace Logo

Conservative Management of HSIL in Patients With Future Pregnancy Aspiration

NCT04783805 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2021-03-05

No results posted yet for this study

Summary

Conservative management of high-grade squamous intraepithelial lesions (HSILs) seems safe and justified in young women (\<30 years), but evidence is insufficient on whether it is also advisable for older women.

This study will be conducted to analyze spontaneous HSIL regression rates in women of reproductive age and establish whether conservative HSIL management could be safely recommended to women of childbearing potential, irrespective of age.

This is a single-center prospective observational study that will include consecutive women of reproductive age, referred to a tertiary hospital due to HSIL between March 2021 and December 2025, who prefer conservative management rather than immediate cervical conization.

All patients will be followed-up regularly with colposcopy, cytology, human papillomavirus (HPV) testing and biopsies. In case their lesions progress or HSIL persists after 24 months of follow-up, conization will be indicated. Rates of spontaneous regression or resolution, as well as progression rates, will be assessed. Furthermore, the association between potential predictive factors and HSIL resolution will be analyzed.

Conditions

  • Cervical Intraepithelial Neoplasia
  • Squamous Intraepithelial Lesions of the Cervix
  • Uterine Cervical Dysplasia

Interventions

DIAGNOSTIC_TEST

Conservative management with regular follow-up

Women will be followed-up every 4 months, with colposcopy and cytology at each visit.

PROCEDURE

Conization

Women with progression of HSIL, HSIL persistence after 24 months of follow-up, or that no longer meet the criteria for surveillance will have conization

Sponsors & Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    lead OTHER

Principal Investigators

  • Cristina Vanrell Barbat, MD · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  • Nerea Nerea · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-03
Primary Completion
2025-12-31
Completion
2027-12-31

Countries

  • Spain

Study Locations

More Related Trials

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 NCT04783805 on ClinicalTrials.gov