oncoFISH Cervical Test for Detection of 3q26 Region Gain

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

UNKNOWN

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to evaluate the use of the oncoFISH cervical test system in the management of women who have received an LSIL Pap report to determine whether the test can predict which women will progress to more serious cervical disease and which women do not have to be monitored as closely.

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Detailed Description

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Conditions

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Cervical Cancer LSIL

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LSIL

Women 21 years of age or older with an LSIL diagnosis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Women 21 years of age or greater with recent LSIL who are scheduled for colposcipal assessment.
* Women with previous or current STD or HIV may be included
* Women with previous LSIL history may be included.

Exclusion Criteria

* pregnant women,
* women with vaginal intraepithelial lesions,
* women on a chemotherapeutic agent,
* women with previous or current cancer except for non-cervical squamous cell carcinoma

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes