chemQbiosciences:Manual Liquid Based Cytology

Study Overview
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Brief Summary
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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
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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.

Official Title
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chemQbiosciences:Manual Liquid Based Cytology

Conditions
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Cervical Dysplasia, Cervical Cancer

Intervention / Treatment
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* Procedure: Pap smear


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liquid based cytology<br>All participants will undergo both manual and conventional automated liquid based cytology (pap smear, cervical cytology). | Procedure: Pap smear<br>* 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.<br>* Other names: cervical cytology;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical dysplasia, Cervical cancer