Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
NCT ID: NCT04746872
Last Updated: 2024-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
14935 participants
OBSERVATIONAL
2021-02-16
2022-11-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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 \[(31/ 33/ 52/ 58) and (35/ 39/ 51/ 56/ 59/ 66/ 68)\].
Alinity m HR HPV
A qualitative in vitro test that amplifies and detects HR HPV DNA in cervical tissue samples.
Interventions
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Alinity m HR HPV
A qualitative in vitro test that amplifies and detects HR HPV DNA in cervical tissue samples.
Eligibility Criteria
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Inclusion Criteria
* 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 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
25 Years
FEMALE
No
Sponsors
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Abbott Molecular
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
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
Clinical Trials Management, LLC
Covington, Louisiana, United States
MedPharmics, LLC
Covington, Louisiana, United States
Newman Comprehensive Obgyn
Covington, Louisiana, United States
MedPharmics, LLC
Metairie, 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
Saginaw Valley Medical Research Group
Saginaw, Michigan, United States
Planned Parenthood MN-ND-SD
Saint Paul, Minnesota, United States
MedPharmics
Gulfport, Mississippi, United States
Meridian Clinical Research
Hastings, Nebraska, United States
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, United States
Dr. Nader and Associates
Las Vegas, Nevada, United States
Rex Garn Mabey
Las Vegas, Nevada, United States
Capital Health - Lawrence Ob-Gyn Associates PC
Lawrenceville, New Jersey, United States
Carolina Institute for Clinical Research
Fayetteville, North Carolina, United States
Eastern Carolina Women's Center
New Bern, North Carolina, United States
Unified Women's Clinical Research -Raleigh
Raleigh, North Carolina, United States
Unified Women's Clinical Research- Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Cleveland MacDonald Women's Hospital
Cleveland, Ohio, United States
Hilltop Obstetrics & Gynecology, Inc.
Franklin, Ohio, United States
The Ohio State University Obstetrics and Gynecology Worthington
Worthington, Ohio, United States
The Ohio State University Obstetrics and Gynecology Worthington
Worthington, Ohio, United States
OB GYN Associates of Erie
Erie, Pennsylvania, United States
VitaLink Research - Greenville
Greenville, South Carolina, United States
Tribe Clinical Research dba Mountain View Clinical Research
Greer, 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
Christina Sebestyen MD, P.A. dba OBGYN North
Austin, Texas, United States
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
Ventavia Research Group
Fort Worth, Texas, United States
TMC Life Research, Inc.
Houston, Texas, United States
Cedar Health Research, LLC_Avacare West
Irving, Texas, United States
Medical Colleagues of Texas, LLP
Katy, Texas, United States
Physicians Research Options
Draper, Utah, United States
Tidewater Clinical Research Inc
Norfolk, Virginia, United States
Countries
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Other Identifiers
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V560-02-20S07-01
Identifier Type: -
Identifier Source: org_study_id
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