NCT04115787

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 104 (estimated)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2019-10-14
• Primary completion: 2019-11-28
• Completion: 2019-12-28
• First posted: 2019-10-04
• Last updated: 2019-10-04

Locations

1 site across 1 country: Spain