NCT01234480

Intended Use Study of the BD SurePath Plus™ Pap

• Status: Terminated
• Phase: —
• Study type: Interventional
• Enrollment: 5,859 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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

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

Interventions

Type	Name	Description
DEVICE	BD SurePath Plus Pap test	BD SurePath Plus Pap test
DEVICE	BD SurePath Pap test	BD SurePath Plus Pap test
PROCEDURE	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
DEVICE	HPV DNA test	digene HC2 HPV DNA test

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-03-01
• Completion: 2012-08-01
• First posted: 2010-11-04
• Last updated: 2023-05-16
• Results posted: 2021-05-05

Locations

1 site across 1 country: United States