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chemQbiosciences:Manual Liquid Based Cytology

NCT01837303 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 76

Last updated 2013-12-04

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Lisa Rahangdale, MD, MPH · University of North Carolina

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01837303 on ClinicalTrials.gov