RecruitingNCT04783805

Conservative Management of HSIL in Patients With Future Pregnancy Aspiration

Conservative Management of Patients Diagnosed With High-grade Squamous Intraepithelial Lesions (H-SIL) Who Have Pregnancy Intentions: a Prospective Observational Study


Sponsor

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

Enrollment

200 participants

Start Date

Mar 3, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study explores whether women with HSIL (high-grade cervical cell changes — a pre-cancerous condition) who want to have children in the future can safely be monitored closely (watchful waiting) rather than having immediate treatment that may affect the cervix and future pregnancies. **You may be eligible if...** - You are of reproductive age and want to have children in the future - You agree to close follow-up and monitoring - A colposcopy (specialized cervical exam) shows high-grade changes that are fully visible and do not involve the inside of the cervical canal - The abnormal area covers less than 50% of the cervix **You may NOT be eligible if...** - You are currently pregnant or become pregnant during the study - You have a weakened immune system (from HIV or medications) - There is any suspicion or diagnosis of atypical glandular cells, adenocarcinoma in situ, or cervical cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTConservative management with regular follow-up

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

PROCEDUREConization

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


Locations(1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

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NCT04783805


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