Managing high-grade cervical lesions in women planning future pregnancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the rates of spontaneous regression of high-grade squamous intraepithelial lesions (HSIL) in women of reproductive age who prefer conservative management instead of immediate surgical treatment. Conducted at a tertiary hospital, the study will follow participants with regular colposcopy, cytology, HPV testing, and biopsies over a period of up to 24 months. The goal is to determine whether conservative management can be safely recommended for women of childbearing potential, regardless of age, while monitoring for any progression of lesions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Reproductive age and aspirations of future pregnancies
* Acceptance of conservative management
* Commitment to attend scheduled follow-up visits
* Colposcopy with transformation zone (ZT) type 1 or 2 (fully visible squamous-columnar union) with lesion with grade 2 changes visible in its entirety. No endocervical involvement
* Colposcopy with grade 2 changes that are not extensive: \<50% of the cervical surface

Exclusion Criteria:

* Pregnancy at first visit or during follow-up.
* Immunosuppression (either iatrogenic or due to human immunodeficiency virus (HIV))
* Suspected or diagnosed Atypical Glandular Cells (ACG), In Situ Adenocarcinoma (AIS) or Cervical Cancer (CC)

Where it's running

• Hospital de la Santa Creu i Sant Pau
  Barcelona, Spain Recruiting

Study contacts

• Principal investigator: Nerea Nerea — Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Study coordinator: Natalia Teixeira, MD, Ph.D.
• Email: nteixeira@santpau.cat
• Phone: +34604311873

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.