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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-Collected Cervical Pap Smear | Experimental | women will receive a self Papanicolaou Smear test (SoloPap) in addition to their physician-collected Papanicolaou Smear |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-Collected Cervical Pap Smear | Device | Patient-Collected Cervical Papanicolaou Smear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests | whether the SoloPap™ cervical cell sample collection kit used by the subject (patient) is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Opinions | Results from a survey about simple subject attitudes regarding the SoloPap. Patient Solo Pap Kit Questions
| Directly after interventions (Solo Pap and physician-collected pap smear samples) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Crawford, M.D. | Mke O'Callaghan Federal Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mike O'Callaghan Federal Hospital/Nellis Air Force Base | Las Vegas | Nevada | 89191 | United States |
Of the 150 participants enrolled, 146 participants received all study interventions (comparison of a self-collected Pap smear with Physician-collected samples).
150 females, age >18, without severe hand arthritis were recruited at the Mike O'Callaghan Military Medical Center (formerly Mike O'Callaghan Federal Hospital). The first participant was enrolled January 19, 2011 and the last patient enrolled was September 1, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Self Pap Smear and Physician Collected Pap Smear | (solopap) self-collected Pap smear and Physician-collected samples. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
146 females, age >18
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| ID | Title | Description |
|---|---|---|
| BG000 | Solopap and Physician-collected Pap Smear | females, age >18, without severe hand arthritis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests | whether the SoloPap™ cervical cell sample collection kit used by the subject (patient) is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females. | Posted | Count of Participants | Participants | 1 hour |
|
|
1 hour for each participant during pap procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self Pap Smear | SoloPap: Patient-Collected Cervical Papanicolaou Smears Self Pap Smear |
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Limitations:
Higher socioeconomic status of participants
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Crawford | Mike O'Callaghan Military Medical Center | 702-653-3583 | amanda.j.crawford.ctr@health.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 23, 2011 | May 20, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Patient Opinions | Results from a survey about simple subject attitudes regarding the SoloPap. Patient Solo Pap Kit Questions
| 146 females recruited from an outpatient clinic in a military treatment facility, age >18, without severe hand arthritis who completed both the Solo Pap and physician-collected pap smear. | Posted | Count of Participants | Participants | Directly after interventions (Solo Pap and physician-collected pap smear samples) |
|
|
|
| 0 |
| 150 |
| 0 |
| 150 |
| 0 |
| 150 |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| use solopap in future |
|
| recommend solopap |
|