Intended Use Study of the BD SurePath Plus™ Pap

Study Overview
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Brief Summary
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This study will provide data on the performance of the BD SurePath Plus™ Pap test for identifying high grade cervical disease. This study will be conducted with approximately 12,500 women undergoing routine cervical cancer screening, of whom women with abnormal cytology and/or positive HPV test will be selected to undergo colposcopy and biopsy/ECC. Subjects with abnormal cytology results with biopsy results of less than or equal to CIN1 or CIN2 untreated will be asked to return in 6-8 months for follow-up testing. Subjects may be asked to proceed to a longer-term follow-up study and undergo cytological evaluation annually for 3 years (separate study).

Detailed Description
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This is a pivotal, multi-center in vitro diagnostic study comparing the BD SurePath Plus Pap test to current practice (cytologic examination utilizing the BD SurePath liquid-based Pap test with conjunctive HPV testing) for the detection of cervical cancer and high-grade cervical disease (collectively referred to as CIN2+) in women. The new BD SurePath Plus Pap Test combines a traditional Papanicolaou staining for cellular morphology, with brown nuclear immunostaining resulting from the over-expression of specific protein biomarkers, on one slide, to improve the detection of high-grade cervical disease and cervical cancer (collectively referred to as CIN2+).

Official Title
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Intended Use Study of the BD SurePath Plus™ Pap

Conditions
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Uterine Cervical Neoplasms, Uterine Cervical Cancer, Neoplasms, Squamous Cell, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Papilloma

Intervention / Treatment
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* Device: BD SurePath Plus Pap test
* Device: BD SurePath Pap test
* Procedure: colposcopy with biopsy/ECC
* Device: HPV DNA test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study subjects must give voluntary written informed consent to participate in this study. - Females ages 18 - 35 years, inclusive; or women at high- risk for cervical cancer or its precursor lesions. High-risk is defined as: Have had a previous high-risk HPV positive test in the last 5 years; or Have had an abnormal Pap test (ASC-US or higher) in the last 5 years; or Have not been screened for cervical cancer by either a Pap test or HPV test in the last 5 years. Exclusion Criteria: Subjects who are 36 years of age or greater who are not high risk, and/or: Have not had an abnormal Pap in the last 5 years; or Have not had a positive HPV test in the last 5 years; or Have been screened in the last 5 years without an abnormal Pap or HPV result Subjects known to be pregnant or planning to become pregnant prior to the potential six months follow-up visit (self-reported). Subjects who decide to become pregnant prior to the six-month follow up visit or found to be pregnant after the first visit, but prior to the six-month follow-up visit will be terminated from further study participation at that time Subjects who have had a prior complete or partial hysterectomy involving removal of the cervix. Subjects who have had an application of chemical compounds to the cervical area within the 24 hours prior to study entry, e.g., acetic acid, iodine, spermicide, douche, anti-fungal medications, etc. Subjects on whom conization, LEEP, laser surgery, or cryosurgery has been performed within the past five months. Subjects currently undergoing radiation and/or chemotherapy. Subjects under the age of 18. Subjects who have previously received a HPV vaccine with any number of doses.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with Cervical Disease<br>Participants positive for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC. | Device: BD SurePath Plus Pap test<br>* BD SurePath Plus Pap test<br>Device: BD SurePath Pap test<br>* BD SurePath Plus Pap test<br>Procedure: colposcopy with biopsy/ECC<br>* Colposcopy with biopsy/ECC for subjects with 1)BD SurePath Pap NILM, but HPV positive, or 2) BD SurePath Plus Pap test result of ASC-US or higher 3)BD SurePath Pap ASC-US or higher<br>Device: HPV DNA test<br>* digene HC2 HPV DNA test<br>* Other names: digene HC2 HPV DNA test;|
| Experimental: Participants without Cervical Disease<br>Participants negative for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC. | Device: BD SurePath Plus Pap test<br>* BD SurePath Plus Pap test<br>Device: BD SurePath Pap test<br>* BD SurePath Plus Pap test<br>Device: HPV DNA test<br>* digene HC2 HPV DNA test<br>* Other names: digene HC2 HPV DNA test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher | Estimate the sensitivity, specificity, positive predictive value and negative predictive value of the BD SurePath Plus Pap test in detecting cervical disease as defined as CIN2 or higher | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the Sensitivity and Specificity of the BD SurePath Plus Pap Test to the SurePath Pap With HPV Reflex Testing for CIN2+ Disease Detection. |  | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liquid based cytology, Surepath