Clinician-Collected Versus Patient-Collected Cervical Pap Smears

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Device: Patient-Collected Cervical Pap Smear

• Registration Number: NCT01214330
• Lead Sponsor: Mike O'Callaghan Military Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-05
• Study Start: 2011-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2014-10-10
• Results First Submitted QC: 2014-11-04
• Results First Posted: 2014-11-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient-Collected Cervical Pap Smear	Patient-Collected Cervical Pap Smear	women will receive a self Papanicolaou Smear test (SoloPap) in addition to their physician-collected Papanicolaou Smear

Primary Outcome Measures

Name	Time	Method
Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests	1 hour	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.

Secondary Outcome Measures

Name	Time	Method
Patient Opinions	Directly after interventions (Solo Pap and physician-collected pap smear samples)	Results from a survey about simple subject attitudes regarding the SoloPap.; Patient Solo Pap Kit Questions; 1. Did you experience any discomfort while using the Solo Pap Kit? Yes / No; 2. Would you use the Solo Pap Kit for future Pap Tests? Yes / No; 3. Would you recommend the Solo Pap Kit to a friend or family member? Yes / No

Trial Locations

Locations (1)

Mike O'Callaghan Federal Hospital/Nellis Air Force Base; 🇺🇸 Las Vegas, Nevada, United States