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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liquid based cytology | All participants will undergo both manual and conventional automated liquid based cytology (pap smear, cervical cytology). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pap smear | Procedure | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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76 healthy women presenting for standard pap smear screening
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Rahangdale, MD, MPH | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Hospitals | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| ID | Term |
|---|---|
| D065006 | Papanicolaou Test |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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|
|
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |