Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
Public ClinicalTrials.gov record NCT04746872. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04746872
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 14,935 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 25 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 16, 2021 (Actual)
- Primary completion
- Jun 16, 2022 (Actual)
- Completion
- Nov 3, 2022 (Actual)
- Last update posted
- Feb 12, 2024
2021 – 2022
United States locations
- U.S. sites
- 63
- U.S. states
- 26
- U.S. cities
- 49
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Hospital | Birmingham | Alabama | 35233 | — |
| MedPharmics, LLC | Phoenix | Arizona | 85012 | — |
| Desert Bloom Family Medicine / West Valley Research Clinic, LLC | Phoenix | Arizona | 85031 | — |
| Quality of Life Medical & Research Centers, LLC | Tucson | Arizona | 85712 | — |
| Visions Clinical Research | Tucson | Arizona | 85712 | — |
| Northern California Research | Sacramento | California | 95821 | — |
| Physicians' Research Options | Lakewood | Colorado | 80228 | — |
| Planned Parenthood of Southern New England | New Haven | Connecticut | 06511 | — |
| David I Lubetkin, MD, LLC | Boca Raton | Florida | 33486 | — |
| Health Awareness INC | Jupiter | Florida | 33458 | — |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | — |
| Partners in Womens Health of Jupiter, LLC | Jupiter | Florida | 33458 | — |
| Altus Research | Lake Worth | Florida | 33416 | — |
| South Florida Clinical Research | Margate | Florida | 33063 | — |
| South Miami OB-GYN, Associates, LLC | Miami | Florida | 33143 | — |
| Health Awareness, Inc. | Port Saint Lucie | Florida | 34952 | — |
| Physician Care Clinical Research LLC | Sarasota | Florida | 34239 | — |
| Joyce R. Miller, MD, LLC dba South Miami Womens Health an Elligo Health Research Site | South Miami | Florida | 33143 | — |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | — |
| Soapstone Center For Clinical Research | Decatur | Georgia | 30034 | — |
| The Women's Clinic | Boise | Idaho | 83712 | — |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | — |
| Leavitt Women's Healthcare | Idaho Falls | Idaho | 83404 | — |
| Providea Health Partners, LLC an Elligo Health Research Site | Mokena | Illinois | 60448 | — |
| Women's Health Advantage | Fort Wayne | Indiana | 46825 | — |
| Clinical Trials Management, LLC | Covington | Louisiana | 70433 | — |
| MedPharmics, LLC | Covington | Louisiana | 70433 | — |
| Newman Comprehensive Obgyn | Covington | Louisiana | 70433 | — |
| MedPharmics, LLC | Metairie | Louisiana | 70006 | — |
| NECCR Fall River LLC | Fall River | Massachusetts | 02720 | — |
| Valley Ob-Gyn Clinic, PC and Elligo Health Research Site | Saginaw | Michigan | 48602 | — |
| Saginaw Valley Medical Research Group | Saginaw | Michigan | 48604 | — |
| Planned Parenthood MN-ND-SD | Saint Paul | Minnesota | 55114 | — |
| MedPharmics | Gulfport | Mississippi | 39503 | — |
| Meridian Clinical Research | Hastings | Nebraska | 68901 | — |
| Women's Clinic of Lincoln, PC | Lincoln | Nebraska | 68510 | — |
| Dr. Nader and Associates | Las Vegas | Nevada | 89030 | — |
| Rex Garn Mabey | Las Vegas | Nevada | 89128 | — |
| Capital Health - Lawrence Ob-Gyn Associates PC | Lawrenceville | New Jersey | 08648 | — |
| Carolina Institute for Clinical Research | Fayetteville | North Carolina | 28304 | — |
| Eastern Carolina Women's Center | New Bern | North Carolina | 28562 | — |
| Unified Women's Clinical Research -Raleigh | Raleigh | North Carolina | 27606 | — |
| Unified Women's Clinical Research- Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| Cleveland MacDonald Women's Hospital | Cleveland | Ohio | 44106 | — |
| Hilltop Obstetrics & Gynecology, Inc. | Franklin | Ohio | 45005 | — |
| The Ohio State University Obstetrics and Gynecology Worthington | Worthington | Ohio | 43085-2688 | — |
| The Ohio State University Obstetrics and Gynecology Worthington | Worthington | Ohio | 43085 | — |
| OB GYN Associates of Erie | Erie | Pennsylvania | 16507 | — |
| VitaLink Research - Greenville | Greenville | South Carolina | 29615 | — |
| Tribe Clinical Research dba Mountain View Clinical Research | Greer | South Carolina | 29651 | — |
| Medical Research Center of Memphis, LLC | Memphis | Tennessee | 38120 | — |
| Women's Health Texas, LLC (Elligo) | Austin | Texas | 78705 | — |
| Hill Country OB/GYN Associates | Austin | Texas | 78748 | — |
| Austin Area Obgyn, PLLC | Austin | Texas | 78758 | — |
| Christina Sebestyen MD, P.A. dba OBGYN North | Austin | Texas | 78758 | — |
| Nueces County Women's Clinic dba Corpus Christi Women's Clinic an Elligo Health Research Site | Corpus Christi | Texas | 78412 | — |
| Advanced Research Associates | Corpus Christi | Texas | 78414 | — |
| Ventavia Research Group | Fort Worth | Texas | 76104 | — |
| TMC Life Research, Inc. | Houston | Texas | 77054 | — |
| Cedar Health Research, LLC_Avacare West | Irving | Texas | 75062 | — |
| Medical Colleagues of Texas, LLP | Katy | Texas | 77450 | — |
| Physicians Research Options | Draper | Utah | 84020 | — |
| Tidewater Clinical Research Inc | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04746872, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 12, 2024 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04746872 live on ClinicalTrials.gov.