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Trial record 30 of 12473 for:    cervical

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01214330
Recruitment Status : Completed
First Posted : October 5, 2010
Results First Posted : November 20, 2014
Last Update Posted : November 21, 2014
Information provided by (Responsible Party):
Mike O'Callaghan Military Hospital

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Device: Patient-Collected Cervical Pap Smear Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study for a Non-Inferiority Trial of Clinician-Collected Versus Patient-Collected Cervical Papanicolaou Smears
Study Start Date : February 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

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 Name: SoloPap

Primary Outcome Measures :
  1. Concordance (Similarity Between Samples) of Pap Smears [ Time Frame: 1 year ]
    Is the SoloPap collection device as good at detecting cervical dysplasia as a clinician-collected Pap Smear?

Secondary Outcome Measures :
  1. Patient Attitudes [ Time Frame: 6 months ]
    Results from SoloPap Patient Questionairre regarding patient attitudes.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01214330

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United States, Nevada
Mike O'Callaghan Federal Hospital/Nellis Air Force Base
Las Vegas, Nevada, United States, 89191
Sponsors and Collaborators
Mike O'Callaghan Military Hospital
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Principal Investigator: Paul Crawford, M.D. Mke O'Callaghan Federal Hospital

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Responsible Party: Mike O'Callaghan Military Hospital Identifier: NCT01214330     History of Changes
Other Study ID Numbers: FWH20100177H
First Posted: October 5, 2010    Key Record Dates
Results First Posted: November 20, 2014
Last Update Posted: November 21, 2014
Last Verified: November 2014

Keywords provided by Mike O'Callaghan Military Hospital:
cervical cancer

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female