Status:
COMPLETED
Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
Lead Sponsor:
Abbott Molecular
Conditions:
Human Papillomavirus
Eligibility:
FEMALE
25+ years
Brief Summary
A prospective multicenter interventional study will be conducted to enroll women undergoing routine cervical cancer screening to collect cervical liquid-based cytology (LBC) specimen(s). For all subje...
Eligibility Criteria
Inclusion
- Women is eligible if she meets the following:
- Is 25 years of age or older
- Is attending a participating clinic for routine cervical cancer screening following screening guidelines
- Has an intact cervix
- Is willing and able to provide documented informed consent
- Is willing and able to undergo colposcopy, biopsy, and endocervical curettage (ECC) within 12 weeks (≤ 84 days) from the baseline visit, if required
- Is willing and able to allow collection of two cervical cytology specimens
Exclusion
- A women is ineligible for the study if she meets any of the following criteria:
- Is pregnant at the time of visit or plans to become pregnant within the following 12 weeks
- Has any known medical condition that, in the opinion of the investigator, would result in increased risk of bleeding at biopsy
- Has a known history of excisional or ablative therapy (e.g., LEEP, cone biopsy, cervical laser surgery, or cryotherapy) to the cervix in the last 12 months prior to the baseline visit
- Had a cervical cytology specimen collected within the last 4 months
- Is currently participating in any diagnostic trial for cervical cancer
- Had a complete or partial hysterectomy, either supra cervical or involving removal of the cervix
- Is currently participating or planning to participate in any clinical trial for HPV treatment (for the duration of this study)
- Previous participation in this study
Key Trial Info
Start Date :
February 16 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 3 2022
Estimated Enrollment :
14935 Patients enrolled
Trial Details
Trial ID
NCT04746872
Start Date
February 16 2021
End Date
November 3 2022
Last Update
February 12 2024
Active Locations (63)
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1
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States, 35233
2
MedPharmics, LLC
Phoenix, Arizona, United States, 85012
3
Desert Bloom Family Medicine / West Valley Research Clinic, LLC
Phoenix, Arizona, United States, 85031
4
Quality of Life Medical & Research Centers, LLC
Tucson, Arizona, United States, 85712