oncoFISH Cervical Test for Detection of 3q26 Region Gain

The oncoFISH Cervical Test for Detection of 3q26 Region Gain

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01416922

Enrollment

1100

Registered

2011-08-15

Start date

2009-06-30

Completion date

2011-12-31

Last updated

2011-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, LSIL

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

Yes

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

Countries

United States

Outcome results