NCT02331550

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

9 months

First QC Date

January 3, 2015

Last Update Submit

September 25, 2016

Conditions

LSIL, Low-Grade Squamous Intraepithelial Lesions

Keywords

Low-Grade Squamous Intraepithelial Lesions

Outcome Measures

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.

    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.

    12 months

Study Arms (2)

Expectant treatment

EXPERIMENTAL

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

Ablative treatment

EXPERIMENTAL

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

Interventions

Ablative treatmentPROCEDURE

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

Ablative treatment
Expectant managementPROCEDURE

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

Expectant treatment

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Low-Grade Squamous Intraepithelial Lesion by cervical cytology.
  • Positive Biopsy for Low-Grade Squamous Intraepithelial Lesion after colposcopy.

You may not qualify if:

  • Serological detection of human immunodeficiency virus (HIV).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas H

Panama City, Provincia de Panamá, Panama

Location

MeSH Terms

Conditions

Squamous Intraepithelial Lesions

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Morphological and Microscopic FindingsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Osvaldo Reyes, MD

    Saint Thomas Hospital, Panama

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator of Research

Study Record Dates

First Submitted

January 3, 2015

First Posted

January 6, 2015

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

PA(1)