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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient-Collected Cervical Pap Smear
Sponsored by
Mike O'Callaghan Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring cervical cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Mike O'Callaghan Federal Hospital/Nellis Air Force Base

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient-Collected Cervical Pap Smear

Arm Description

women will receive a self Papanicolaou Smear test (SoloPap) in addition to their physician-collected Papanicolaou Smear

Outcomes

Primary Outcome Measures

Concordance (Similarity Between Samples) of Pap Smears
Is the SoloPap collection device as good at detecting cervical dysplasia as a clinician-collected Pap Smear?

Secondary Outcome Measures

Patient Attitudes
Results from SoloPap Patient Questionairre regarding patient attitudes.

Full Information

First Posted
September 30, 2010
Last Updated
November 20, 2014
Sponsor
Mike O'Callaghan Military Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01214330
Brief Title
Clinician-Collected Versus Patient-Collected Cervical Pap Smears
Acronym
SoloPaP
Official Title
A Pilot Study for a Non-Inferiority Trial of Clinician-Collected Versus Patient-Collected Cervical Papanicolaou Smears
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mike O'Callaghan Military Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
cervical cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient-Collected Cervical Pap Smear
Arm Type
Experimental
Arm Description
women will receive a self Papanicolaou Smear test (SoloPap) in addition to their physician-collected Papanicolaou Smear
Intervention Type
Device
Intervention Name(s)
Patient-Collected Cervical Pap Smear
Other Intervention Name(s)
SoloPap
Intervention Description
Patient-Collected Cervical Papanicolaou Smear
Primary Outcome Measure Information:
Title
Concordance (Similarity Between Samples) of Pap Smears
Description
Is the SoloPap collection device as good at detecting cervical dysplasia as a clinician-collected Pap Smear?
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Patient Attitudes
Description
Results from SoloPap Patient Questionairre regarding patient attitudes.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Crawford, M.D.
Organizational Affiliation
Mke O'Callaghan Federal Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mike O'Callaghan Federal Hospital/Nellis Air Force Base
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89191
Country
United States

12. IPD Sharing Statement

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Clinician-Collected Versus Patient-Collected Cervical Pap Smears

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