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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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)]. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alinity m HR HPV | Diagnostic Test | A qualitative in vitro test that amplifies and detects HR HPV DNA in cervical tissue samples. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Progression greater than or equal to (cervical intraepithelial neoplasia) CIN3 | Diagnosis of greater than or equal to CIN3 (cervical intraepithelial neoplasia) is based on central pathology review panel histologic result. | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease progression greater than or equal to cervical intraepithelial neoplasia (CIN2) | Diagnosis of greater than or equal to CIN2 (cervical intraepithelial neoplasia) is based on central pathology review panel histologic result. | Baseline to 12 weeks |
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Inclusion Criteria:
Women is eligible if she meets the following:
Exclusion Criteria:
A women is ineligible for the study if she meets any of the following criteria:
The participant must be biologically female.
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Woman who are ≥25 years of age who are high risk humpapillomarius (HPV).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Hospital | Birmingham | Alabama | 35233 | United States | ||
| MedPharmics, LLC |
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Tissue sample
| Phoenix |
| Arizona |
| 85012 |
| United States |
| Desert Bloom Family Medicine / West Valley Research Clinic, LLC | Phoenix | Arizona | 85031 | United States |
| Quality of Life Medical & Research Centers, LLC | Tucson | Arizona | 85712 | United States |
| Visions Clinical Research | Tucson | Arizona | 85712 | United States |
| Northern California Research | Sacramento | California | 95821 | United States |
| Physicians' Research Options | Lakewood | Colorado | 80228 | United States |
| Planned Parenthood of Southern New England | New Haven | Connecticut | 06511 | United States |
| David I Lubetkin, MD, LLC | Boca Raton | Florida | 33486 | United States |
| Health Awareness INC | Jupiter | Florida | 33458 | United States |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | United States |
| Partners in Womens Health of Jupiter, LLC | Jupiter | Florida | 33458 | United States |
| Altus Research | Lake Worth | Florida | 33416 | United States |
| South Florida Clinical Research | Margate | Florida | 33063 | United States |
| South Miami OB-GYN, Associates, LLC | Miami | Florida | 33143 | United States |
| Health Awareness, Inc. | Port Saint Lucie | Florida | 34952 | United States |
| Physician Care Clinical Research LLC | Sarasota | Florida | 34239 | United States |
| Joyce R. Miller, MD, LLC dba South Miami Womens Health an Elligo Health Research Site | South Miami | Florida | 33143 | United States |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | United States |
| Soapstone Center For Clinical Research | Decatur | Georgia | 30034 | United States |
| The Women's Clinic | Boise | Idaho | 83712 | United States |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | United States |
| Leavitt Women's Healthcare | Idaho Falls | Idaho | 83404 | United States |
| Providea Health Partners, LLC an Elligo Health Research Site | Mokena | Illinois | 60448 | United States |
| Women's Health Advantage | Fort Wayne | Indiana | 46825 | United States |
| Clinical Trials Management, LLC | Covington | Louisiana | 70433 | United States |
| MedPharmics, LLC | Covington | Louisiana | 70433 | United States |
| Newman Comprehensive Obgyn | Covington | Louisiana | 70433 | United States |
| MedPharmics, LLC | Metairie | Louisiana | 70006 | United States |
| NECCR Fall River LLC | Fall River | Massachusetts | 02720 | United States |
| Valley Ob-Gyn Clinic, PC and Elligo Health Research Site | Saginaw | Michigan | 48602 | United States |
| Saginaw Valley Medical Research Group | Saginaw | Michigan | 48604 | United States |
| Planned Parenthood MN-ND-SD | Saint Paul | Minnesota | 55114 | United States |
| MedPharmics | Gulfport | Mississippi | 39503 | United States |
| Meridian Clinical Research | Hastings | Nebraska | 68901 | United States |
| Women's Clinic of Lincoln, PC | Lincoln | Nebraska | 68510 | United States |
| Dr. Nader and Associates | Las Vegas | Nevada | 89030 | United States |
| Rex Garn Mabey | Las Vegas | Nevada | 89128 | United States |
| Capital Health - Lawrence Ob-Gyn Associates PC | Lawrenceville | New Jersey | 08648 | United States |
| Carolina Institute for Clinical Research | Fayetteville | North Carolina | 28304 | United States |
| Eastern Carolina Women's Center | New Bern | North Carolina | 28562 | United States |
| Unified Women's Clinical Research -Raleigh | Raleigh | North Carolina | 27606 | United States |
| Unified Women's Clinical Research- Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland MacDonald Women's Hospital | Cleveland | Ohio | 44106 | United States |
| Hilltop Obstetrics & Gynecology, Inc. | Franklin | Ohio | 45005 | United States |
| The Ohio State University Obstetrics and Gynecology Worthington | Worthington | Ohio | 43085-2688 | United States |
| The Ohio State University Obstetrics and Gynecology Worthington | Worthington | Ohio | 43085 | United States |
| OB GYN Associates of Erie | Erie | Pennsylvania | 16507 | United States |
| VitaLink Research - Greenville | Greenville | South Carolina | 29615 | United States |
| Tribe Clinical Research dba Mountain View Clinical Research | Greer | South Carolina | 29651 | United States |
| Medical Research Center of Memphis, LLC | Memphis | Tennessee | 38120 | United States |
| Women's Health Texas, LLC (Elligo) | Austin | Texas | 78705 | United States |
| Hill Country OB/GYN Associates | Austin | Texas | 78748 | United States |
| Austin Area Obgyn, PLLC | Austin | Texas | 78758 | United States |
| Christina Sebestyen MD, P.A. dba OBGYN North | Austin | Texas | 78758 | United States |
| Nueces County Women's Clinic dba Corpus Christi Women's Clinic an Elligo Health Research Site | Corpus Christi | Texas | 78412 | United States |
| Advanced Research Associates | Corpus Christi | Texas | 78414 | United States |
| Ventavia Research Group | Fort Worth | Texas | 76104 | United States |
| TMC Life Research, Inc. | Houston | Texas | 77054 | United States |
| Cedar Health Research, LLC_Avacare West | Irving | Texas | 75062 | United States |
| Medical Colleagues of Texas, LLP | Katy | Texas | 77450 | United States |
| Physicians Research Options | Draper | Utah | 84020 | United States |
| Tidewater Clinical Research Inc | Norfolk | Virginia | 23502 | United States |
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007239 | Infections |
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