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

September 25, 2016 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama, Panama
        • Saint Thomas H

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Expectant treatment
Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that were managed with observation and evaluation at 6 and 12 months after diagnosis.
Procedure: Expectant management
Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions were managed with observation and evaluation at 6 and 12 months after diagnosis.
Experimental: Ablative treatment
Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that were managed with an ablative treatment and evaluated at 6 and 12 months after diagnosis.
Procedure: Ablative treatment
Use of an ablative treatment (cryotherapy) for the management of Low-Grade Squamous Intraepithelial Lesions of the cervix.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Thomas Hospital, Panama

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 3, 2015

First Submitted That Met QC Criteria

January 5, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 25, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHST2014-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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