Clinical trial NCT04115787: Conservative Management in Patients Diagnosed With Grade 2 or Grade 3 CIN
Official title: Conservative Management in Patients Diagnosed With Grade 2 or Grade 3 CIN
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: High-Grade Squamous Intraepithelial Lesions
Neoplasm Regression, Spontaneous
Disease Progression
Papillomavirus Infections
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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)
* Provided that inclusion criteria are not met

Primary outcomes:
measure: H-SIL Resolution
timeFrame: 24 months
measure: H-SIL Regression
timeFrame: 24 months
Secondary outcomes:
measure: Factors probably related to the resolution
timeFrame: 24 months
measure: Strict resolution
timeFrame: 24 months
measure: Lenient resolution
timeFrame: 24 months
measure: Conization surgery
timeFrame: 24 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Nerea Luqui Scarcelli
Study officials:
References: