Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening

NCT04746872 | Completed FDA Device

• 1 other identifier: V560-02-20S07-01
• Study Type: observational
• Target: 14,935
• Locations: 1 country
• Sites: 63

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.

Conditions

Human Papillomavirus

Keywords

HPV; Virus; Cervical; Cancer; Oncology; Screening; tissue collection; biopsy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Disease progression greater than or equal to cervical intraepithelial neoplasia (CIN2)

  Baseline to 12 weeks

Study Arms (1)

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 \[(31/ 33/ 52/ 58) and (35/ 39/ 51/ 56/ 59/ 66/ 68)\].

Diagnostic Test: Alinity m HR HPV

Interventions

Alinity m HR HPV DIAGNOSTIC_TEST

A qualitative in vitro test that amplifies and detects HR HPV DNA in cervical tissue samples.

Alinity m HR HPV

Eligibility Criteria

• Age: 25 Years+
• Gender Eligibility Details: The participant must be biologically female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Woman who are ≥25 years of age who are high risk humpapillomarius (HPV).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Molecular: lead

Study Sites (63)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35233, United States

Location

MedPharmics, LLC

Phoenix, Arizona, 85012, United States

Location

Desert Bloom Family Medicine / West Valley Research Clinic, LLC

Phoenix, Arizona, 85031, United States

Location

Quality of Life Medical & Research Centers, LLC

Tucson, Arizona, 85712, United States

Location

Visions Clinical Research

Tucson, Arizona, 85712, United States

Location

Northern California Research

Sacramento, California, 95821, United States

Location

Physicians' Research Options

Lakewood, Colorado, 80228, United States

Location

Planned Parenthood of Southern New England

New Haven, Connecticut, 06511, United States

Location

David I Lubetkin, MD, LLC

Boca Raton, Florida, 33486, United States

Location

Health Awareness INC

Jupiter, Florida, 33458, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

Partners in Womens Health of Jupiter, LLC

Jupiter, Florida, 33458, United States

Location

Altus Research

Lake Worth, Florida, 33416, United States

Location

South Florida Clinical Research

Margate, Florida, 33063, United States

Location

South Miami OB-GYN, Associates, LLC

Miami, Florida, 33143, United States

Location

Health Awareness, Inc.

Port Saint Lucie, Florida, 34952, United States

Location

Physician Care Clinical Research LLC

Sarasota, Florida, 34239, United States

Location

Joyce R. Miller, MD, LLC dba South Miami Womens Health an Elligo Health Research Site

South Miami, Florida, 33143, United States

Location

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, 33409, United States

Location

Soapstone Center For Clinical Research

Decatur, Georgia, 30034, United States

Location

The Women's Clinic

Boise, Idaho, 83712, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Leavitt Women's Healthcare

Idaho Falls, Idaho, 83404, United States

Location

Providea Health Partners, LLC an Elligo Health Research Site

Mokena, Illinois, 60448, United States

Location

Women's Health Advantage

Fort Wayne, Indiana, 46825, United States

Location

Clinical Trials Management, LLC

Covington, Louisiana, 70433, United States

Location

MedPharmics, LLC

Covington, Louisiana, 70433, United States

Location

Newman Comprehensive Obgyn

Covington, Louisiana, 70433, United States

Location

MedPharmics, LLC

Metairie, Louisiana, 70006, United States

Location

NECCR Fall River LLC

Fall River, Massachusetts, 02720, United States

Location

Valley Ob-Gyn Clinic, PC and Elligo Health Research Site

Saginaw, Michigan, 48602, United States

Location

Saginaw Valley Medical Research Group

Saginaw, Michigan, 48604, United States

Location

Planned Parenthood MN-ND-SD

Saint Paul, Minnesota, 55114, United States

Location

MedPharmics

Gulfport, Mississippi, 39503, United States

Location

Meridian Clinical Research

Hastings, Nebraska, 68901, United States

Location

Women's Clinic of Lincoln, PC

Lincoln, Nebraska, 68510, United States

Location

Dr. Nader and Associates

Las Vegas, Nevada, 89030, United States

Location

Rex Garn Mabey

Las Vegas, Nevada, 89128, United States

Location

Capital Health - Lawrence Ob-Gyn Associates PC

Lawrenceville, New Jersey, 08648, United States

Location

Carolina Institute for Clinical Research

Fayetteville, North Carolina, 28304, United States

Location

Eastern Carolina Women's Center

New Bern, North Carolina, 28562, United States

Location

Unified Women's Clinical Research -Raleigh

Raleigh, North Carolina, 27606, United States

Location

Unified Women's Clinical Research- Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland MacDonald Women's Hospital

Cleveland, Ohio, 44106, United States

Location

Hilltop Obstetrics & Gynecology, Inc.

Franklin, Ohio, 45005, United States

Location

The Ohio State University Obstetrics and Gynecology Worthington

Worthington, Ohio, 43085-2688, United States

Location

The Ohio State University Obstetrics and Gynecology Worthington

Worthington, Ohio, 43085, United States

Location

OB GYN Associates of Erie

Erie, Pennsylvania, 16507, United States

Location

VitaLink Research - Greenville

Greenville, South Carolina, 29615, United States

Location

Tribe Clinical Research dba Mountain View Clinical Research

Greer, South Carolina, 29651, United States

Location

Medical Research Center of Memphis, LLC

Memphis, Tennessee, 38120, United States

Location

Women's Health Texas, LLC (Elligo)

Austin, Texas, 78705, United States

Location

Hill Country OB/GYN Associates

Austin, Texas, 78748, United States

Location

Austin Area Obgyn, PLLC

Austin, Texas, 78758, United States

Location

Christina Sebestyen MD, P.A. dba OBGYN North

Austin, Texas, 78758, United States

Location

Nueces County Women's Clinic dba Corpus Christi Women's Clinic an Elligo Health Research Site

Corpus Christi, Texas, 78412, United States

Location

Advanced Research Associates

Corpus Christi, Texas, 78414, United States

Location

Ventavia Research Group

Fort Worth, Texas, 76104, United States

Location

TMC Life Research, Inc.

Houston, Texas, 77054, United States

Location

Cedar Health Research, LLC_Avacare West

Irving, Texas, 75062, United States

Location

Medical Colleagues of Texas, LLP

Katy, Texas, 77450, United States

Location

Physicians Research Options

Draper, Utah, 84020, United States

Location

Tidewater Clinical Research Inc

Norfolk, Virginia, 23502, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue sample

MeSH Terms

Conditions

Virus Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: February 16, 2021
• Primary Completion: June 16, 2022
• Study Completion: November 3, 2022
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

US (63)