Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
- Conditions
- Human Papillomavirus
- Interventions
- Diagnostic Test: Alinity m HR HPV
- Registration Number
- NCT04746872
- Lead Sponsor
- Abbott Molecular
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 14935
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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Alinity m HR HPV Alinity m HR HPV The Alinity m HR HPV IUO assay is a qualitative in vitro test that amplifies and detects HR HPV DNA in cervical cells collected in liquid media. The assay can differentiate between HPV 16, HPV 18, HPV 45 and non-HPV 16/18/45 genotypes \[(31/ 33/ 52/ 58) and (35/ 39/ 51/ 56/ 59/ 66/ 68)\].
- Primary Outcome Measures
Name Time Method Disease Progression greater than or equal to (cervical intraepithelial neoplasia) CIN3 Baseline to 12 weeks Diagnosis of greater than or equal to CIN3 (cervical intraepithelial neoplasia) is based on central pathology review panel histologic result.
- Secondary Outcome Measures
Name Time Method Disease progression greater than or equal to cervical intraepithelial neoplasia (CIN2) Baseline to 12 weeks Diagnosis of greater than or equal to CIN2 (cervical intraepithelial neoplasia) is based on central pathology review panel histologic result.
Trial Locations
- Locations (59)
Nueces County Women's Clinic dba Corpus Christi Women's Clinic an Elligo Health Research Site
🇺🇸Corpus Christi, Texas, United States
Advanced Research Associates
🇺🇸Corpus Christi, Texas, United States
Visions Clinical Research
🇺🇸Tucson, Arizona, United States
South Florida Clinical Research
🇺🇸Margate, Florida, United States
Partners in Womens Health of Jupiter, LLC
🇺🇸Jupiter, Florida, United States
Providea Health Partners, LLC an Elligo Health Research Site
🇺🇸Mokena, Illinois, United States
South Miami OB-GYN, Associates, LLC
🇺🇸Miami, Florida, United States
University of Alabama at Birmingham Hospital
🇺🇸Birmingham, Alabama, 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
Planned Parenthood MN-ND-SD
🇺🇸Saint Paul, Minnesota, United States
David I Lubetkin, MD, LLC
🇺🇸Boca Raton, Florida, United States
Northern California Research
🇺🇸Sacramento, California, United States
Planned Parenthood of Southern New England
🇺🇸New Haven, Connecticut, United States
MedPharmics, LLC
🇺🇸Metairie, Louisiana, United States
Physicians' Research Options
🇺🇸Lakewood, Colorado, United States
Health Awareness INC
🇺🇸Jupiter, Florida, United States
Health Awareness, Inc.
🇺🇸Port Saint Lucie, Florida, United States
Altus Research
🇺🇸Lake Worth, Florida, United States
Physician Care Clinical Research LLC
🇺🇸Sarasota, Florida, United States
The Women's Clinic
🇺🇸Boise, Idaho, United States
Women's Health Advantage
🇺🇸Fort Wayne, Indiana, United States
Clinical Trials Management, LLC
🇺🇸Covington, Louisiana, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Newman Comprehensive Obgyn
🇺🇸Covington, Louisiana, United States
NECCR Fall River LLC
🇺🇸Fall River, Massachusetts, United States
Valley Ob-Gyn Clinic, PC and Elligo Health Research Site
🇺🇸Saginaw, Michigan, United States
Meridian Clinical Research
🇺🇸Hastings, Nebraska, United States
Carolina Institute for Clinical Research
🇺🇸Fayetteville, North Carolina, United States
Unified Women's Clinical Research -Raleigh
🇺🇸Raleigh, North Carolina, United States
Eastern Carolina Women's Center
🇺🇸New Bern, North Carolina, United States
Comprehensive Clinical Trials, LLC
🇺🇸West Palm Beach, Florida, United States
Soapstone Center For Clinical Research
🇺🇸Decatur, Georgia, United States
Hilltop Obstetrics & Gynecology, Inc.
🇺🇸Franklin, Ohio, United States
Saginaw Valley Medical Research Group
🇺🇸Saginaw, Michigan, United States
MedPharmics
🇺🇸Gulfport, Mississippi, United States
OB GYN Associates of Erie
🇺🇸Erie, Pennsylvania, United States
Leavitt Women's Healthcare
🇺🇸Idaho Falls, Idaho, United States
Capital Health - Lawrence Ob-Gyn Associates PC
🇺🇸Lawrenceville, New Jersey, United States
Women's Clinic of Lincoln, PC
🇺🇸Lincoln, Nebraska, United States
Cleveland MacDonald Women's Hospital
🇺🇸Cleveland, Ohio, United States
Rex Garn Mabey
🇺🇸Las Vegas, Nevada, United States
Unified Women's Clinical Research- Lyndhurst Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Medical Colleagues of Texas, LLP
🇺🇸Katy, Texas, United States
The Ohio State University Obstetrics and Gynecology Worthington
🇺🇸Worthington, Ohio, United States
Dr. Nader and Associates
🇺🇸Las Vegas, Nevada, United States
VitaLink Research - Greenville
🇺🇸Greenville, South Carolina, United States
Medical Research Center of Memphis, LLC
🇺🇸Memphis, Tennessee, United States
Women's Health Texas, LLC (Elligo)
🇺🇸Austin, Texas, United States
Hill Country OB/GYN Associates
🇺🇸Austin, Texas, United States
Austin Area Obgyn, PLLC
🇺🇸Austin, Texas, United States
Tribe Clinical Research dba Mountain View Clinical Research
🇺🇸Greer, South Carolina, United States
TMC Life Research, Inc.
🇺🇸Houston, Texas, United States
Cedar Health Research, LLC_Avacare West
🇺🇸Irving, Texas, United States
Ventavia Research Group
🇺🇸Fort Worth, Texas, United States
Physicians Research Options
🇺🇸Draper, Utah, United States
Tidewater Clinical Research Inc
🇺🇸Norfolk, Virginia, United States
Christina Sebestyen MD, P.A. dba OBGYN North
🇺🇸Austin, Texas, United States
Joyce R. Miller, MD, LLC dba South Miami Womens Health an Elligo Health Research Site
🇺🇸South Miami, Florida, United States