Clinician-Collected Versus Patient-Collected Cervical Pap Smears

NCT01214330 | Completed Results

• 1 other identifier: FWH20100177H
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

cervical cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Opinions

  Directly after interventions (Solo Pap and physician-collected pap smear samples)

Study Arms (1)

Patient-Collected Cervical Pap Smear

EXPERIMENTAL

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

Device: Patient-Collected Cervical Pap Smear

Interventions

Patient-Collected Cervical Pap Smear DEVICE

Patient-Collected Cervical Papanicolaou Smear

Also known as: SoloPap

Patient-Collected Cervical Pap Smear

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

Study Sites (1)

Mike O'Callaghan Federal Hospital/Nellis Air Force Base

Las Vegas, Nevada, 89191, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Limitations: Higher socioeconomic status of participants

Results Point of Contact

• Title: Amanda Crawford
• Organization: Mike O'Callaghan Military Medical Center

amanda.j.crawford.ctr@health.mil

702-653-3583

Study Officials

• Paul Crawford, M.D.

  Mke O'Callaghan Federal Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 5, 2010
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 12, 2024
• Results First Posted: November 20, 2014

Record last verified: 2024-02

Locations

US (1)