chemQbiosciences:Manual Liquid Based Cytology
18 Years
N/A
Female
Cervical Dysplasia, Cervical Cancer
Trial Information
chemQbiosciences:Manual Liquid Based Cytology
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.
Inclusion Criteria:
- Female ages 18 years or older
- English speaking
- Presenting for pap smear examination
Exclusion Criteria:
- Pregnancy
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Cross-Sectional
Outcome Measure:
Compare cytologic outcomes using manual liquid based cytology to conventional
Outcome Description:
A single board certified Pathologist will blindly review the study pap smear and clinical pap smear. There results will be compared for differences.
Outcome Time Frame:
4 months
Safety Issue:
No
Principal Investigator
Lisa Rahangdale, MD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of North Carolina
Authority:
United States: Institutional Review Board
Study ID:
13-1341
NCT ID:
NCT01837303
Start Date:
May 2013
Completion Date:
October 2013
Related Keywords:
- Cervical Dysplasia
- Cervical Cancer
- Cervical dysplasia
- Cervical cancer
- Uterine Cervical Neoplasms
- Uterine Cervical Dysplasia
- Cervical Intraepithelial Neoplasia
Name | Location |
|---|---|
| University of North Carolina Hospitals | Chapel Hill, North Carolina 27599 |
