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chemQbiosciences:Manual Liquid Based Cytology

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Completed
CT.gov ID
NCT01837303
Collaborator
(none)
76
Enrollment
1
Location
4
Duration (Months)
18.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Purpose: To assess equivalence between low cost manual liquid based cytology (pap smear) and standard Thin prep cytology screening.

Participants: 100-120 healthy women presenting for standard pap smear screening

Procedures (methods): After routine care pap smear, another pap smear will be performed and placed in the study medium. Clinical care pap and study pap will be reviewed by a single pathologist to assess for equivalent findings.

Hypothesis: Manual liquid based cytology is equivalent to conventional liquid based cytology.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pap smear

Detailed Description

Purpose: To assess equivalence between low cost manual liquid based cytology (pap smear) and standard Thin prep cytology screening.

Participants: 100-120 healthy women presenting for standard pap smear screening

Procedures (methods): After routine care pap smear, another pap smear will be performed and placed in the study medium. The study pap medium will be processed using the manufacturers instructions and then clinical care pap and study pap will be reviewed by a single pathologist to assess for equivalent findings.

Study Design

Study Type:
Observational
Actual Enrollment :
76 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
chemQbiosciences:Manual Liquid Based Cytology
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Liquid based cytology

All participants will undergo both manual and conventional automated liquid based cytology (pap smear, cervical cytology).

Procedure: Pap smear
A pap smear/cervical cytology is performed using a spatula and brush to obtain cells from the ectocervical and endocervical region of the cervix. The specimen will be collected twice to put in the standard clinical pap medium and another to put in the study pap medium. These slides will be processed so that they may be reviewed by a single board certified pathologist. There are no other interventions or follow up. All participants will undergo the above described procedures. There is no placebo.
Other Names:
  • cervical cytology

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Compare cytologic outcomes using manual liquid based cytology to conventional [4 months]

      A single board certified Pathologist will blindly review the study pap smear and clinical pap smear. There results will be compared for differences.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Female ages 18 years or older

    • English speaking

    • Presenting for pap smear examination

    Exclusion Criteria:
    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of North Carolina Hospitals Chapel Hill North Carolina United States 27599

    Sponsors and Collaborators

    • University of North Carolina, Chapel Hill

    Investigators

    • Principal Investigator: Lisa Rahangdale, MD, MPH, University of North Carolina

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of North Carolina, Chapel Hill
    ClinicalTrials.gov Identifier:
    NCT01837303
    Other Study ID Numbers:
    • 13-1341
    First Posted:
    Apr 23, 2013
    Last Update Posted:
    Dec 4, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by University of North Carolina, Chapel Hill
    Cervical dysplasia
    Cervical cancer
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms
    Uterine Cervical Dysplasia
    Cervical Intraepithelial Neoplasia

    Study Results

    No Results Posted as of Dec 4, 2013