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chemQbiosciences:Manual Liquid Based Cytology


N/A
18 Years
N/A
Not Enrolling
Female
Cervical Dysplasia, Cervical Cancer

Thank you

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