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

NCT ID: NCT04115787

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-14
• Study Completion Date: 2019-12-28

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 2012 to December 2016, which meet the inclusion criteria, have voluntarily manifested pregnancy intendedness and had a minimum follow-up time of 2 years and a maximum of 7.

The aim is to evaluate whether the HSIL resolution rates (CIN 2 or CIN 3) are sufficient to support conservative management.

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 colposcopy exam findings to confirm H-SIL or cervical cancer. Follow-up is spaced every 6 months if the cytology and biopsy results indicate L-SIL / ASCUS in agreement with the colposcopic image. HPV tests are performed every 8-12 months. This strategy is maintained until the resolution of the H-SIL.

The conservative management stops if the H-SIL lesion persists after 24 months of follow-up, if the inclusion criteria are no longer met or if the exclusion ones are met.

Inclusion and exclusion criteria are reviewed at each visit and the conservative management ceases in case the patient decides to undergo conization.

Conditions

High-Grade Squamous Intraepithelial Lesions; Neoplasm Regression, Spontaneous; Disease Progression; Papillomavirus Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nerea Luqui Scarcelli

Barcelona, , Spain

Countries

Spain

Other Identifiers

IIBSP-CIN-2019-50

Identifier Type: -

Identifier Source: org_study_id