Intended Use Study of the BD SurePath Plus™ Pap

Neoplasms Clinical Trial

Official title: Intended Use Study of the BD SurePath Plus™ Pap

Status Terminated

Clinical Trial 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).

Clinical Trial 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+). ;

Related Conditions & MeSH terms

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

• NCT number: NCT01234480
• Study type: Interventional
• Source: Becton, Dickinson and Company
• Status: Terminated
• Start date: September 2010
• Completion date: August 2012