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Trial record 19 of 280 for:    Panama

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

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ClinicalTrials.gov Identifier: NCT02331550
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

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

Condition or disease Intervention/treatment Phase
LSIL, Low-Grade Squamous Intraepithelial Lesions Procedure: Ablative treatment Procedure: Expectant management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions. Retrospective Paired Cohort Study.
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331550


Locations
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Panama
Saint Thomas H
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
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Principal Investigator: Osvaldo Reyes, MD Saint Thomas Hospital, Panama

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Responsible Party: Osvaldo A. Reyes T., Coordinator of Research, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT02331550     History of Changes
Other Study ID Numbers: MHST2014-01
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Low-Grade Squamous Intraepithelial Lesions
Additional relevant MeSH terms:
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Squamous Intraepithelial Lesions of the Cervix
Uterine Cervical Dysplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female