Status:
UNKNOWN
oncoFISH Cervical Test for Detection of 3q26 Region Gain
Lead Sponsor:
Ikonisys, Inc.
Conditions:
Cervical Cancer
LSIL
Eligibility:
FEMALE
21+ years
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 wo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT01416922
Start Date
June 1 2009
End Date
December 1 2011
Last Update
August 15 2011
Active Locations (1)
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1
Ikonisys
New Haven, Connecticut, United States, 06511