Status:
RECRUITING
Conservative Management of HSIL in Patients With Future Pregnancy Aspiration
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Conditions:
Cervical Intraepithelial Neoplasia
Squamous Intraepithelial Lesions of the Cervix
Eligibility:
FEMALE
Brief 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 ol...
Detailed Description
In most developed countries, two main strategies are currently used for cervical cancer prevention: primary prevention with human papillomavirus (HPV) vaccination, and systematic screening with period...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04783805
Start Date
March 3 2021
End Date
December 31 2027
Last Update
March 5 2021
Active Locations (1)
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1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041