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oncoFISH Cervical Test for Detection of 3q26 Region Gain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01416922
Recruitment Status : Unknown
Verified August 2011 by Ikonisys, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : August 15, 2011
Last Update Posted : August 15, 2011
Information provided by:
Ikonisys, Inc.

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.

Condition or disease
Cervical Cancer LSIL

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Study Type : Observational
Estimated Enrollment : 1100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The oncoFISH Cervical Test for Detection of 3q26 Region Gain
Study Start Date : June 2009
Estimated Study Completion Date : December 2011

Women 21 years of age or older with an LSIL diagnosis

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients 21 years of age or greater with LSIL cytology diagnosis who are scheduled for a colposcical assessment.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01416922

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United States, Connecticut
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Ikonisys, Inc.
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Study Director: Michael W Kilpatrick, Ph.D. Ikonisys, Inc.
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Responsible Party: CEO, Ikonisys Identifier: NCT01416922    
Obsolete Identifiers: NCT01417039
Other Study ID Numbers: IKON 0801
First Posted: August 15, 2011    Key Record Dates
Last Update Posted: August 15, 2011
Last Verified: August 2011
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases