Intended Use Study of the BD SurePath Plus™ Pap

Stopped early

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

In brief

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

Study ID

NCT01234480

Run by

Becton, Dickinson and Company

People needed

5859

Starts

2010-09-01

Expected to finish

2012-08-01

Last updated by the study team

2023-05-16

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Seattle Women's: Health, Research, Gynecology — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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