chemQbiosciences:Manual Liquid Based Cytology

Completed

• Conditions: Cervical Dysplasia; Cervical Cancer
• Interventions: Procedure: Pap smear

• Registration Number: NCT01837303
• Lead Sponsor: University of North Carolina, Chapel Hill

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 Timeline

• Status Verified: 2013-04
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-23
• Study Start: 2013-05
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

• Female ages 18 years or older
• English speaking
• Presenting for pap smear examination

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Exclusion Criteria

• Pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liquid based cytology	Pap smear	All participants will undergo both manual and conventional automated liquid based cytology (pap smear, cervical cytology).

Primary Outcome Measures

Name	Time	Method
Compare cytologic outcomes using manual liquid based cytology to conventional	4 months	A single board certified Pathologist will blindly review the study pap smear and clinical pap smear. There results will be compared for differences.

Trial Locations

Locations (1)

University of North Carolina Hospitals; 🇺🇸 Chapel Hill, North Carolina, United States