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

LSIL, Low-Grade Squamous Intraepithelial Lesions Clinical Trial

Official title:

Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions. Retrospective Paired Cohort Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331550
• Other study ID #: MHST2014-01
• Status: Completed
• Phase: N/A
• First received: January 3, 2015
• Last updated: September 25, 2016
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: September 2016
• Source: Saint Thomas Hospital, Panama
• Contact: n/a
• Is FDA regulated: No
• Health authority: Panama: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• LSIL, Low-Grade Squamous Intraepithelial Lesions
• Squamous Intraepithelial Lesions of the Cervix

Intervention

Procedure:
• Ablative treatment
Use of an ablative treatment (cryotherapy) for the management of Low-Grade Squamous Intraepithelial Lesions of the cervix.
• Expectant management
Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions were managed with observation and evaluation at 6 and 12 months after diagnosis.

Locations

Country	Name	City	State
Panama	Saint Thomas H	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No