Intended Use Study of the BD SurePath Plus™ Pap

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

5859 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-08-31

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).

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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+).

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BD SurePath Plus Pap test

Intervention Type DEVICE

BD SurePath Pap test

BD SurePath Plus Pap test

Intervention Type DEVICE

colposcopy with biopsy/ECC

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

Intervention Type PROCEDURE

HPV DNA test

digene HC2 HPV DNA test

Intervention Type DEVICE

Other Intervention Names

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digene HC2 HPV DNA test

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:

1. Have not had an abnormal Pap in the last 5 years; or
2. Have not had a positive HPV test in the last 5 years; or
3. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No