Status:
ACTIVE_NOT_RECRUITING
Single Visit Clinical Validation of ScreenFire, a Low-cost HPV Test
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Medical College of Wisconsin
University of North Carolina, Chapel Hill
Conditions:
Human Papilloma Virus
Eligibility:
FEMALE
30-59 years
Phase:
NA
Brief Summary
The purpose of this study is to validate a new low-cost, self-collected HPV screening test (ScreenFire) and compare it to the standard provider collected careHPV, for the detection of high grade cervi...
Detailed Description
Study Design: Interventional study Study Procedures: Enrollment: We originally anticipated enrolling 12,000 women from clinics in El Salvador. However, preliminary results showed that HPV positivit...
Eligibility Criteria
Inclusion
- Female, aged 30-59
Exclusion
- Pregnancy at time of colposcopy/biopsy
- Hysterectomy with surgically absent cervix
- Cervical cancer screening in the past two years
- Prior diagnosis or treatment of invasive cervical cancer
Key Trial Info
Start Date :
February 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
9100 Patients enrolled
Trial Details
Trial ID
NCT05431699
Start Date
February 13 2023
End Date
December 1 2027
Last Update
September 15 2025
Active Locations (1)
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1
Ministerio de Salud
San Salvador, El Salvador