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

Primary Purpose

LSIL, Low-Grade Squamous Intraepithelial Lesions

Status
Completed
Phase
Not Applicable
Locations
Panama
Study Type
Interventional
Intervention
Ablative treatment
Expectant management
Sponsored by
Saint Thomas Hospital, Panama
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for LSIL, Low-Grade Squamous Intraepithelial Lesions focused on measuring Low-Grade Squamous Intraepithelial Lesions

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Saint Thomas H

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Expectant treatment

Ablative treatment

Arm Description

Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that were managed with observation and evaluation at 6 and 12 months after diagnosis.

Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that were managed with an ablative treatment and evaluated at 6 and 12 months after diagnosis.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 3, 2015
Last Updated
September 25, 2016
Sponsor
Saint Thomas Hospital, Panama
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1. Study Identification

Unique Protocol Identification Number
NCT02331550
Brief Title
Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions.
Official Title
Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions. Retrospective Paired Cohort Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Thomas Hospital, Panama

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
LSIL, Low-Grade Squamous Intraepithelial Lesions
Keywords
Low-Grade Squamous Intraepithelial Lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expectant treatment
Arm Type
Experimental
Arm Description
Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that were managed with observation and evaluation at 6 and 12 months after diagnosis.
Arm Title
Ablative treatment
Arm Type
Experimental
Arm Description
Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that were managed with an ablative treatment and evaluated at 6 and 12 months after diagnosis.
Intervention Type
Procedure
Intervention Name(s)
Ablative treatment
Intervention Description
Use of an ablative treatment (cryotherapy) for the management of Low-Grade Squamous Intraepithelial Lesions of the cervix.
Intervention Type
Procedure
Intervention Name(s)
Expectant management
Intervention Description
Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions were managed with observation and evaluation at 6 and 12 months after diagnosis.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osvaldo Reyes, MD
Organizational Affiliation
Saint Thomas Hospital, Panama
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Thomas H
City
Panama
Country
Panama

12. IPD Sharing Statement

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

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