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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Disease Progression
High-Grade Squamous Intraepithelial Lesions
Neoplasm Regression, Spontaneous
Papillomavirus Infections
Squamous Intraepithelial Lesions of the Cervix

Clinical Trial Details

NCT number	NCT04115787
Study type	Observational
Source	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact
Status	Not yet recruiting
Phase
Start date	October 14, 2019
Completion date	December 28, 2019

View Details

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