chemQbiosciences:Manual Liquid Based Cytology

University of North Carolina, Chapel Hill76 enrolled

Overview

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.

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

Enrollment

Conditions

Cervical Dysplasia Cervical Cancer

Interventions

Pap smearPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female ages 18 years or older * English speaking * Presenting for pap smear examination Exclusion Criteria: * Pregnancy

Locations (1)

University of North Carolina Hospitals

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Compare cytologic outcomes using manual liquid based cytology to conventional

A single board certified Pathologist will blindly review the study pap smear and clinical pap smear. There results will be compared for differences.

Time frame: 4 months

Data from ClinicalTrials.gov

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