Status:
TERMINATED
Intended Use Study of the BD SurePath Plus™ Pap
Lead Sponsor:
Becton, Dickinson and Company
Conditions:
Uterine Cervical Neoplasms
Uterine Cervical Cancer
Eligibility:
FEMALE
18-35 years
Brief 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 r...
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 conjun...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
5859 Patients enrolled
Trial Details
Trial ID
NCT01234480
Start Date
September 1 2010
End Date
August 1 2012
Last Update
May 16 2023
Active Locations (1)
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1
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, United States, 98105