Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions.

Not Applicable

Completed

• Conditions: LSIL, Low-Grade Squamous Intraepithelial Lesions

• Registration Number: NCT02331550
• Lead Sponsor: Saint Thomas Hospital, Panama

Brief Summary

To evaluate the rate of regression and progression of low-grade squamous intraepithelial lesion comparing expectant vs. ablative treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-10
• Study Completion: 2014-12
• Study First Submitted: 2015-01-03
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-25
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• Diagnosis of Low-Grade Squamous Intraepithelial Lesion by cervical cytology.
• Positive Biopsy for Low-Grade Squamous Intraepithelial Lesion after colposcopy.

Exclusion Criteria

• Serological detection of human immunodeficiency virus (HIV).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that progressed to a higher level lesion (High Grade or cervical cancer) when evaluated at 6 and 12 months after diagnosis.	12 months

Secondary Outcome Measures

Name	Time	Method
Number of patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that regressed to a higher level lesion (High Grade or cervical cancer) when evaluated at 6 and 12 months after diagnosis.	12 months

Trial Locations

Locations (1)

Saint Thomas H; 🇵🇦 Panama, Panama