Brief Title
chemQbiosciences:Manual Liquid Based Cytology
Official Title
chemQbiosciences:Manual Liquid Based Cytology
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.
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 Type
Observational
Primary Outcome
Compare cytologic outcomes using manual liquid based cytology to conventional
Condition
Cervical Dysplasia
Intervention
Pap smear
Study Arms / Comparison Groups
Liquid based cytology
Description: All participants will undergo both manual and conventional automated liquid based cytology (pap smear, cervical cytology).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
76
Start Date
May 2013
Completion Date
September 2013
Primary Completion Date
September 2013
Eligibility Criteria
Inclusion Criteria:
- Female ages 18 years or older
- English speaking
- Presenting for pap smear examination
Exclusion Criteria:
- Pregnancy
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Lisa Rahangdale, MD, MPH, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01837303
Organization ID
13-1341
Responsible Party
Sponsor
Study Sponsor
University of North Carolina, Chapel Hill
Study Sponsor
Lisa Rahangdale, MD, MPH, Principal Investigator, University of North Carolina
Verification Date
April 2013