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
Trial Information
Current as of June 05, 2025
Recruiting
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)
About Fundació Institut De Recerca De L'hospital De La Santa Creu I Sant Pau
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is a leading biomedical research organization based in Barcelona, dedicated to advancing scientific knowledge and improving patient care. Affiliated with the prestigious Hospital de la Santa Creu i Sant Pau, the foundation focuses on translational research across various medical disciplines, fostering innovation through collaboration among researchers, clinicians, and industry partners. It aims to bridge the gap between laboratory discoveries and clinical applications, ultimately enhancing healthcare outcomes and contributing to the global understanding of diseases.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Barcelona, , Spain
Barcelona, , Spain
Patients applied
Trial Officials
Cristina Vanrell Barbat, MD
Study Director
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Nerea Nerea
Principal Investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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