Intended Use Study of the BD SurePath Plus™ Pap

NCT01234480 | Terminated Results

• 1 other identifier: TPO-10-06084
• Study Type: interventional
• Target: 5,859
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher

  Estimate the sensitivity, specificity, positive predictive value and negative predictive value of the BD SurePath Plus Pap test in detecting cervical disease as defined as CIN2 or higher

  10 months

Secondary Outcomes (1)

• Compare the Sensitivity and Specificity of the BD SurePath Plus Pap Test to the SurePath Pap With HPV Reflex Testing for CIN2+ Disease Detection.

  10 months

Study Arms (2)

Participants with Cervical Disease

EXPERIMENTAL

Participants positive for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC.

Device: BD SurePath Plus Pap test; Device: BD SurePath Pap test; Procedure: colposcopy with biopsy/ECC; Device: HPV DNA test

Participants without Cervical Disease

EXPERIMENTAL

Participants negative for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC.

Device: BD SurePath Plus Pap test; Device: BD SurePath Pap test; Device: HPV DNA test

Interventions

BD SurePath Plus Pap test DEVICE

BD SurePath Plus Pap test

Participants with Cervical Disease; Participants without Cervical Disease

BD SurePath Pap test DEVICE

BD SurePath Plus Pap test

Participants with Cervical Disease; Participants without Cervical Disease

colposcopy with biopsy/ECC PROCEDURE

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

Participants with Cervical Disease

HPV DNA test DEVICE

digene HC2 HPV DNA test

Also known as: digene HC2 HPV DNA test

Participants with Cervical Disease; Participants without Cervical Disease

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (1)

Seattle Women's: Health, Research, Gynecology

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

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

Interventions

Papanicolaou Test; Colposcopy; Human Papillomavirus DNA Tests

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Surgical Procedures, Operative; Investigative Techniques; Diagnostic Techniques, Obstetrical and Gynecological; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Molecular Diagnostic Techniques; Genetic Techniques

Results Point of Contact

• Title: Karen Yanson
• Organization: Becton Dickinson

karen_a_yanson@bd.com

410-316-4793

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: November 4, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 16, 2023
• Results First Posted: May 5, 2021

Record last verified: 2023-05

Locations

US (1)