Intended Use Study of the BD SurePath Plus™ Pap

Summary

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).

Key Facts

Interventions

Conditions

Eligibility

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.

Outcome Measures

Locations

Linked Diseases