Clinician-Collected Versus Patient-Collected Cervical Pap Smears

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study for a Non-Inferiority Trial of Clinician-Collected Versus Patient-Collected Cervical Papanicolaou Smears

Conditions
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Cervical Cancer

Intervention / Treatment
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* Device: Patient-Collected Cervical Pap Smear


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient-Collected Cervical Pap Smear<br>women will receive a self Papanicolaou Smear test (SoloPap) in addition to their physician-collected Papanicolaou Smear | Device: Patient-Collected Cervical Pap Smear<br>* Patient-Collected Cervical Papanicolaou Smear<br>* Other names: SoloPap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance (Similarity Between Samples) of Pap Smears | Is the SoloPap collection device as good at detecting cervical dysplasia as a clinician-collected Pap Smear? | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Attitudes | Results from SoloPap Patient Questionairre regarding patient attitudes. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer