Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
76 participants
OBSERVATIONAL
2013-05-31
2013-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Liquid based cytology
All participants will undergo both manual and conventional automated liquid based cytology (pap smear, cervical cytology).
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* English speaking
* Presenting for pap smear examination
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Lisa Rahangdale, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Locations
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University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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13-1341
Identifier Type: -
Identifier Source: org_study_id