Clinician-Collected Versus Patient-Collected Cervical Pap Smears

Cervical Cancer Clinical Trial

— SoloPaP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214330
• Other study ID #: FWH20100177H
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: February 2024
• Source: Mike O'Callaghan Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Device:
• Patient-Collected Cervical Pap Smear
Patient-Collected Cervical Papanicolaou Smear

Locations

Country	Name	City	State
United States	Mike O'Callaghan Federal Hospital/Nellis Air Force Base	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Mike O'Callaghan Military Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 hour
Secondary	Patient Opinions	Results from a survey about simple subject attitudes regarding the SoloPap.; Patient Solo Pap Kit Questions; Did you experience any discomfort while using the Solo Pap Kit? Yes / No; Would you use the Solo Pap Kit for future Pap Tests? Yes / No; 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)