oncoFISH Cervical Test for Detection of 3q26 Region Gain

This study is enrolling participants by invitation only.
Information provided by:
Ikonisys, Inc.
ClinicalTrials.gov Identifier:
First received: August 12, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
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.

Cervical Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The oncoFISH Cervical Test for Detection of 3q26 Region Gain

Further study details as provided by Ikonisys, Inc.:

Estimated Enrollment: 1100
Study Start Date: June 2009
Estimated Study Completion Date: December 2011
Women 21 years of age or older with an LSIL diagnosis


Ages Eligible for Study:   21 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416922

United States, Connecticut
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Ikonisys, Inc.
Study Director: Michael W Kilpatrick, Ph.D. Ikonisys, Inc.
  More Information

Responsible Party: CEO, Ikonisys
ClinicalTrials.gov Identifier: NCT01416922     History of Changes
Obsolete Identifiers: NCT01417039
Other Study ID Numbers: IKON 0801 
Study First Received: August 12, 2011
Last Updated: August 12, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on May 25, 2016