oncoFISH Cervical Test for Detection of 3q26 Region Gain

Ikonysis

Status: Unknown

Conditions: LSIL; Cervical Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01416922

IKON 0801

Details and patient eligibility

About

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.

Enrollment: 1,100 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,100 participants in 1 patient group

LSIL

Description:

Women 21 years of age or older with an LSIL diagnosis