Status:

UNKNOWN

Conservative Management in Patients Diagnosed With Grade 2 or Grade 3 CIN

Lead Sponsor:

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Conditions:

High-Grade Squamous Intraepithelial Lesions

Neoplasm Regression, Spontaneous

Eligibility:

FEMALE

18-50 years

Brief Summary

Consecutive inclusion and collection of information for all women attending the Cervical Disease Unit with an histological diagnosis of grade 2 or grade 3 CIN during the last 5 years, from January 201...

Detailed Description

Follow-up is performed every 4 months with colposcopy, cytology and biopsies. Colposcopy and cytology are performed for all control subjects. The need for biopsy is established according to the colpos...

Eligibility Criteria

Inclusion

  • Reproductive age and willing to get pregnant in the future
  • Acceptance of conservative management
  • Commitment to study visits.
  • Colposcopy with zone of transformation (ZT) type 1 or 2 (Unio esco-columnar totally visible) with image compatible with H-SIL and visible in its entirety.

Exclusion

  • Pregnant women
  • Immunosuppression for human immunodeficiency virus (HIV) or iatrogenic type
  • suspicion or diagnosis of Glandular Cell Atipia (ACG), Adenocarcinoma in situ (AIS) or cervical cancer (CC)
  • Provided that inclusion criteria are not met

Key Trial Info

Start Date :

October 14 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 28 2019

Estimated Enrollment :

104 Patients enrolled

Trial Details

Trial ID

NCT04115787

Start Date

October 14 2019

End Date

December 28 2019

Last Update

October 4 2019

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Nerea Luqui Scarcelli

Barcelona, Spain, 08041