Trial record 2 of 8171 for:    Grade

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:
NCT02331550
First received: January 3, 2015
Last updated: January 5, 2015
Last verified: January 2015
  Purpose
To evaluate the rate of regression and progression of low-grade squamous intraepithelial lesion comparing expectant vs. ablative treatment.

Condition Intervention
LSIL, Low-Grade Squamous Intraepithelial Lesions
Procedure: Ablative treatment
Procedure: Expectant management

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions. Retrospective Paired Cohort Study.

Resource links provided by NLM:


Further study details as provided by Saint Thomas Hospital, Panama:

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: January 2014
Study Completion Date: December 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to the Colposcopic Unit of Saint Thomas Hospital for the diagnosis of Low-Grade Squamous Intraepithelial Lesions, between January 2010 and December 2013.
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02331550

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

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 
Study First Received: January 3, 2015
Last Updated: January 5, 2015
Health Authority: Panama: Ministry of Health

Keywords provided by Saint Thomas Hospital, Panama:
Low-Grade Squamous Intraepithelial Lesions

Additional relevant MeSH terms:
Squamous Intraepithelial Lesions of the Cervix
Uterine Cervical Dysplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 25, 2016