Clinical trial NCT01234480: Intended Use Study of the BD SurePath Plus™ Pap
Official title: Intended Use Study of the BD SurePath Plus™ Pap
Study type: INTERVENTIONAL
Overall status: TERMINATED
Conditions: Uterine Cervical Neoplasms
Uterine Cervical Cancer
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Papilloma
Keywords: Liquid based cytology
Surepath
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2010-11-04
Enrollment: 5859
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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+).

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
timeFrame: 10 months
Secondary outcomes:
measure: Compare the Sensitivity and Specificity of the BD SurePath Plus Pap Test to the SurePath Pap With HPV Reflex Testing for CIN2+ Disease Detection.
timeFrame: 10 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Women's: Health, Research, Gynecology
state: Washington
Study officials:
References: