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Cervical Cancer Screening Test

Participants with Cervical Disease for Tumors

N/A
Waitlist Available
Research Sponsored by Becton, Dickinson and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 months
Awards & highlights

Study 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).

Eligible Conditions
  • Tumors
  • Cervical Cancer
  • Warts
  • Cancer
  • Neoplasms
  • Squamous Cell Neoplasms

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
Secondary outcome measures
Compare the Sensitivity and Specificity of the BD SurePath Plus Pap Test to the SurePath Pap With HPV Reflex Testing for CIN2+ Disease Detection.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Participants without Cervical DiseaseExperimental Treatment3 Interventions
Participants negative for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC.
Group II: Participants with Cervical DiseaseExperimental Treatment4 Interventions
Participants positive for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC.

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Who is running the clinical trial?

Becton, Dickinson and CompanyLead Sponsor
70 Previous Clinical Trials
82,727 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Intended Use Study of the BD SurePath Plus™ Pap
2010. "Intended Use Study of the BD SurePath Plus™ Pap". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01234480.
~399 spots leftby May 2025
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