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

NCT ID: NCT02331550

Last Updated: 2016-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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Conditions

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LSIL, Low-Grade Squamous Intraepithelial Lesions

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Expectant treatment

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

Group Type EXPERIMENTAL

Expectant management

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Ablative treatment

Intervention Type PROCEDURE

Use of an ablative treatment (cryotherapy) for the management of Low-Grade Squamous Intraepithelial Lesions of the cervix.

Interventions

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Ablative treatment

Use of an ablative treatment (cryotherapy) for the management of Low-Grade Squamous Intraepithelial Lesions of the cervix.

Intervention Type PROCEDURE

Expectant management

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

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Saint Thomas Hospital, Panama

OTHER

Sponsor Role lead

Responsible Party

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Osvaldo A. Reyes T.

Coordinator of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osvaldo Reyes, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Thomas Hospital, Panama

Locations

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Saint Thomas H

Panama City, Provincia de Panamá, Panama

Site Status

Countries

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Panama

Other Identifiers

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MHST2014-01

Identifier Type: -

Identifier Source: org_study_id

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