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

NCT04115787 | Unknown

• 1 other identifier: IIBSP-CIN-2019-50
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

High-Grade Squamous Intraepithelial Lesions; Neoplasm Regression, Spontaneous; Disease Progression; Papillomavirus Infections

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Factors probably related to the resolution

  24 months

• Strict resolution

  24 months

• Lenient resolution

  24 months

• Conization surgery

  24 months

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Nerea Luqui Scarcelli

Barcelona, 08041, Spain

Location

MeSH Terms

Conditions

Squamous Intraepithelial Lesions; Neoplasm Regression, Spontaneous; Disease Progression; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Pathologic Processes; Disease Attributes; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: October 14, 2019
• Primary Completion: November 28, 2019
• Study Completion: December 28, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Locations

ES (1)