Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening

Completed

Conditions studied: Human Papillomavirus

In brief

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 subjects, two cervical specimens will be collected, and one placed into Hologic ThinPrep Pap Test collection kit with PreservCyt Solution (also referred to as ThinPrep specimen) and the other into BD SurePath liquid-based Pap test (also referred to as SurePath specimen). Cytology and HR HPV results will be generated and utilized to determine need for subject referral to colposcopy. Collection of an endocervical curettage (ECC) specimen, and biopsy(ies) if applicable, from women who are referred to colposcopy as a follow up will be conducted according to a standardized protocol. Disease status for each subject will be determined based on cytology, HPV test results, and/or consensus histology review of cervical biopsy specimens.

Key facts

Study ID

NCT04746872

Run by

Abbott Molecular

People needed

14935

Starts

2021-02-16

Expected to finish

2022-11-03

Last updated by the study team

2024-02-12

Who can join

Age: 25 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MedPharmics, LLC — Phoenix, Arizona, United States
• Desert Bloom Family Medicine / West Valley Research Clinic, LLC — Phoenix, Arizona, United States
• Quality of Life Medical & Research Centers, LLC — Tucson, Arizona, United States
• Visions Clinical Research — Tucson, Arizona, United States
• Northern California Research — Sacramento, California, United States
• Physicians' Research Options — Lakewood, Colorado, United States
• Planned Parenthood of Southern New England — New Haven, Connecticut, United States
• David I Lubetkin, MD, LLC — Boca Raton, Florida, United States
• Health Awareness INC — Jupiter, Florida, United States
• Health Awareness, Inc. — Jupiter, Florida, United States
• Partners in Womens Health of Jupiter, LLC — Jupiter, Florida, United States
• Altus Research — Lake Worth, Florida, United States
• South Florida Clinical Research — Margate, Florida, United States
• South Miami OB-GYN, Associates, LLC — Miami, Florida, United States
• Health Awareness, Inc. — Port Saint Lucie, Florida, United States
• Physician Care Clinical Research LLC — Sarasota, Florida, United States
• Joyce R. Miller, MD, LLC dba South Miami Womens Health an Elligo Health Research Site — South Miami, Florida, United States
• Comprehensive Clinical Trials, LLC — West Palm Beach, Florida, United States
• Soapstone Center For Clinical Research — Decatur, Georgia, United States
• The Women's Clinic — Boise, Idaho, United States
• Clinical Research Prime — Idaho Falls, Idaho, United States
• Leavitt Women's Healthcare — Idaho Falls, Idaho, United States
• Providea Health Partners, LLC an Elligo Health Research Site — Mokena, Illinois, United States
• Women's Health Advantage — Fort Wayne, Indiana, United States
• University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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