Spots Global Cancer Trial Database for Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
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Trial Identification
Brief Title: Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
Official Title: Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
Study ID: NCT04746872
Conditions
Interventions
Study Description
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:
Eligibility
Minimum Age: 25 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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
Contact Details
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