Skip to main content
OpenTrials
Completed

NCT Number: NCT01214330

Clinician-Collected Versus Patient-Collected Cervical Pap 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mike O'Callaghan Federal Hospital/Nellis Air Force Base

Las Vegas, Nevada, 89191, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient-Collected Cervical Pap Smear

Device

Patient-Collected Cervical Papanicolaou Smear

Other names: SoloPap

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    • 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

Sponsors and collaborators

Lead sponsor

Mike O'Callaghan Military Hospital

Fed

Registry information

Official study title

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

Acronym: SoloPaP

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 5, 2010
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.