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

Papillomavirus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04115787
• Other study ID #: IIBSP-CIN-2019-50
• Status: Not yet recruiting
• Start date: October 14, 2019
• Est. completion date: December 28, 2019

Study information

• Verified date: October 2019
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: December 28, 2019
• Est. primary completion date: November 28, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Spain	Nerea Luqui Scarcelli	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H-SIL Resolution	In cases where H-SIL (cytologic, histological and colposcopic) is no longer detected during follow-up.; Include the strict resolution, indulgent resolution and regression	24 months
Primary	H-SIL Regression	H-SIL is not detected, but with a low grade cytological, histologic or colposcopic lesion	24 months
Secondary	Factors probably related to the resolution	Demographics (age and origin), viral type, cytology, biopsy and colposcopy will be recorded at the beginning and end of the follow-up, as well as time until resolution, regression or progression and conization result.	24 months
Secondary	Strict resolution	Negative HPV determination or different from the initial	24 months
Secondary	Lenient resolution	Colposcopy lesion disappearance, negative results on cytology and biopsies with persistence of the same viral type of high initial grade.	24 months
Secondary	Conization surgery	Patients undergoing surgery	24 months