Clinician-Collected Versus Patient-Collected Cervical Pap Smears (SoloPaP)

Mike O'Callaghan Military Hospital

Status

Completed

Conditions

Cervical Cancer

Treatments

Device: Patient-Collected Cervical Pap Smear

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01214330

FWH20100177H

Details and patient eligibility

About

The purpose of this study is to see if it is possible to conduct a full study to determine whether the SoloPap™ cervical cell sample collection kit is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females.

Begin to determine patient attitudes regarding ease of use and discomfort using SoloPap.

Full description

The SoloPap "kit" provides to subjects who would not otherwise have a Pap smear done a convenient and private way to collect samples and ship them to a laboratory for processing. The current study is pilot/pre-cursor study for a larger subsequent study that aims to determine whether SoloPap is truly noninferior to clinician-collected Pap smears in detecting cervical pathology. It will also determine user preference and willingness to perform a self- test.

Enrollment

150 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
All women at least 18 yrs of presenting for Pap Smear who have not previously participated in this protocol. SoloPap can be performed any day that a woman is not having vaginal bleeding

Exclusion criteria

Age <18 years (not recommended for Pap Smear)
Known pregnancy
Women who have had a total hysterectomy (cervix removed)
Women with vaginal bleeding
Persons who report a history of severe neuropathy or arthritis of the hands or those having other major problems with dexterity of the hands