LSIL, Low-Grade Squamous Intraepithelial Lesions Clinical Trial
Official title:
Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions. Retrospective Paired Cohort Study.
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 |
To evaluate the rate of regression and progression of low-grade squamous intraepithelial lesion comparing expectant vs. ablative treatment.
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). |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Panama | Saint Thomas H | Panama |
Lead Sponsor | Collaborator |
---|---|
Saint Thomas Hospital, Panama |
Panama,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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