Conservative Management of HSIL in Patients With Future Pregnancy Aspiration

Launched by FUNDACIÓ INSTITUT DE RECERCA DE L'HOSPITAL DE LA SANTA CREU I SANT PAU · Mar 4, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach for women with high-grade squamous intraepithelial lesions (HSIL), which are changes in the cervix that can lead to cancer. The focus is on whether conservative management—monitoring the condition instead of immediately performing surgery—can be a safe option for women who want to have children in the future. The trial aims to find out how often HSIL resolves on its own and whether this approach can be recommended for women of all ages who are still able to have children.

To be eligible for the study, participants need to be of reproductive age and interested in future pregnancies, willing to choose the conservative management option, and committed to attending regular follow-up visits. They should have specific types of HSIL that are not extensive and have no signs of more serious conditions like cervical cancer. During the trial, participants will have regular check-ups that include tests to monitor their condition. If their HSIL does not improve after two years or worsens, they may need to consider a surgical procedure. This study is important for understanding how to best manage HSIL in younger and older women who wish to maintain their fertility.

Gender

FEMALE

Eligibility criteria

• 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)