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Completed

NCT Number: NCT02331550

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

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

Completed

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Key information

Conditions

LSIL, Low-Grade Squamous Intraepithelial Lesions Morphological and Microscopic Findings Pathological Conditions, Signs and Symptoms Squamous Intraepithelial Lesions

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Thomas H

Panama City, Provincia de Panamá, Panama

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ablative Treatment

Procedure

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

Expectant management

Procedure

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

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 6, 2015
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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