Papillomavirus Infections Clinical Trial
Official title:
Conservative Management in Patients Diagnosed With Grade 2 or Grade 3 CIN
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.
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.
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