NCT01416922UnknownNot Applicable
The oncoFISH Cervical Test for Detection of 3q26 Region Gain
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Ikonisys, Inc.
- Enrollment
- 1,100
- Locations
- 1
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Investigators
Study Sites (1)
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