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.

Study Overview

• Status: Unknown
• Conditions: Disease Progression; Papillomavirus Infections; High-Grade Squamous Intraepithelial Lesions; Neoplasm Regression, Spontaneous

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.

• Study Type: Observational
• Enrollment (Anticipated): 104

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Nerea Luqui Scarcelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
H-SIL Regression	H-SIL is not detected, but with a low grade cytological, histologic or colposcopic lesion	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Strict resolution	Negative HPV determination or different from the initial	24 months
Lenient resolution	Colposcopy lesion disappearance, negative results on cytology and biopsies with persistence of the same viral type of high initial grade.	24 months
Conization surgery	Patients undergoing surgery	24 months

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Anticipated): October 14, 2019
• Primary Completion (Anticipated): November 28, 2019
• Study Completion (Anticipated): December 28, 2019

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Neoplasms; Disease Attributes; DNA Virus Infections; Neoplastic Processes; Tumor Virus Infections; Disease Progression; Papillomavirus Infections; Neoplasm Regression, Spontaneous
• Other Study ID Numbers: IIBSP-CIN-2019-50

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No