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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Page 1 of 1 (1 locations)

1

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain, 08041