NCT01416922

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 15, 2011

Status Verified

August 1, 2011

First QC Date

August 12, 2011

Last Update Submit

August 12, 2011

Conditions

Cervical CancerLSIL

Study Arms (1)

LSIL

Women 21 years of age or older with an LSIL diagnosis

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients 21 years of age or greater with LSIL cytology diagnosis who are scheduled for a colposcical assessment.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ikonisys

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Michael W Kilpatrick, Ph.D.

    Ikonisys, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 12, 2011

First Posted

August 15, 2011

Study Start

June 1, 2009

Study Completion

December 1, 2011

Last Updated

August 15, 2011

Record last verified: 2011-08

Locations

US(1)