oncoFISH Cervical Test for Detection of 3q26 Region Gain

Status unconfirmed

Conditions studied: Cervical Cancer, LSIL

In brief

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.

Key facts

Study ID

NCT01416922

Run by

Ikonisys, Inc.

People needed

1100

Starts

2009-06-01

Expected to finish

2011-12-01

Last updated by the study team

2011-08-15

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Ikonisys — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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