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

February 12, 2024 updated by: Mike O'Callaghan Military Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89191
        • Mike O'Callaghan Federal Hospital/Nellis Air Force Base

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient-Collected Cervical Pap Smear
women will receive a self Papanicolaou Smear test (SoloPap) in addition to their physician-collected Papanicolaou Smear
Device: Patient-Collected Cervical Pap Smear
Patient-Collected Cervical Papanicolaou Smear
Other Names:
  • SoloPap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests
Time Frame: 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.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Opinions
Time Frame: 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
Directly after interventions (Solo Pap and physician-collected pap smear samples)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mike O'Callaghan Military Hospital

Investigators

  • Principal Investigator: Paul Crawford, M.D., Mke O'Callaghan Federal Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 30, 2010

First Submitted That Met QC Criteria

October 1, 2010

First Posted (Estimated)

October 5, 2010

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWH20100177H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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