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

February 8, 2024 updated by: Abbott Molecular
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

14935

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama At Birmingham Hospital
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • MedPharmics, LLC
      • Phoenix, Arizona, United States, 85031
        • Desert Bloom Family Medicine / West Valley Research Clinic, LLC
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research
      • Tucson, Arizona, United States, 85712
        • Quality of Life Medical & Research Centers, LLC
    • California
      • Sacramento, California, United States, 95821
        • Northern California Research
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Physicians' Research Options
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Planned Parenthood of Southern New England
    • Florida
      • Boca Raton, Florida, United States, 33486
        • David I Lubetkin, MD, LLC
      • Jupiter, Florida, United States, 33458
        • Health Awareness, Inc.
      • Jupiter, Florida, United States, 33458
        • Health Awareness INC
      • Jupiter, Florida, United States, 33458
        • Partners in Womens Health of Jupiter, LLC
      • Lake Worth, Florida, United States, 33416
        • Altus Research
      • Margate, Florida, United States, 33063
        • South Florida Clinical Research
      • Miami, Florida, United States, 33143
        • South Miami OB-GYN, Associates, LLC
      • Port Saint Lucie, Florida, United States, 34952
        • Health Awareness, Inc.
      • Sarasota, Florida, United States, 34239
        • Physician Care Clinical Research LLC
      • South Miami, Florida, United States, 33143
        • Joyce R. Miller, MD, LLC dba South Miami Womens Health an Elligo Health Research Site
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials, Llc
    • Georgia
      • Decatur, Georgia, United States, 30034
        • Soapstone Center for Clinical Research
    • Idaho
      • Boise, Idaho, United States, 83712
        • The Women's Clinic
      • Idaho Falls, Idaho, United States, 83404
        • Clinical Research Prime
      • Idaho Falls, Idaho, United States, 83404
        • Leavitt Women's Healthcare
    • Illinois
      • Mokena, Illinois, United States, 60448
        • Providea Health Partners, LLC an Elligo Health Research Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Women's Health Advantage
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • MedPharmics, LLC
      • Covington, Louisiana, United States, 70433
        • Clinical Trials Management, LLC
      • Covington, Louisiana, United States, 70433
        • Newman Comprehensive Obgyn
      • Metairie, Louisiana, United States, 70006
        • MedPharmics, LLC
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • NECCR Fall River LLC
    • Michigan
      • Saginaw, Michigan, United States, 48604
        • Saginaw Valley Medical Research Group
      • Saginaw, Michigan, United States, 48602
        • Valley Ob-Gyn Clinic, PC and Elligo Health Research Site
    • Minnesota
      • Saint Paul, Minnesota, United States, 55114
        • Planned Parenthood MN-ND-SD
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • MedPharmics
    • Nebraska
      • Hastings, Nebraska, United States, 68901
        • Meridian Clinical Research
      • Lincoln, Nebraska, United States, 68510
        • Women's Clinic of Lincoln, PC
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Rex Garn Mabey
      • Las Vegas, Nevada, United States, 89030
        • Dr. Nader and Associates
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Capital Health - Lawrence Ob-Gyn Associates PC
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Carolina Institute for Clinical Research
      • New Bern, North Carolina, United States, 28562
        • Eastern Carolina Women's Center
      • Raleigh, North Carolina, United States, 27606
        • Unified Women's Clinical Research -Raleigh
      • Winston-Salem, North Carolina, United States, 27103
        • Unified Women's Clinical Research- Lyndhurst Clinical Research
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Cleveland MacDonald Women's Hospital
      • Franklin, Ohio, United States, 45005
        • Hilltop Obstetrics & Gynecology, Inc.
      • Worthington, Ohio, United States, 43085-2688
        • The Ohio State University Obstetrics and Gynecology Worthington
      • Worthington, Ohio, United States, 43085
        • The Ohio State University Obstetrics and Gynecology Worthington
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • OB GYN Associates of Erie
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • VitaLink Research - Greenville
      • Greer, South Carolina, United States, 29651
        • Tribe Clinical Research dba Mountain View Clinical Research
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Medical Research Center of Memphis, LLC
    • Texas
      • Austin, Texas, United States, 78705
        • Women's Health Texas, LLC (Elligo)
      • Austin, Texas, United States, 78748
        • Hill Country OB/GYN Associates
      • Austin, Texas, United States, 78758
        • Austin Area Obgyn, PLLC
      • Austin, Texas, United States, 78758
        • Christina Sebestyen MD, P.A. dba OBGYN North
      • Corpus Christi, Texas, United States, 78414
        • Advanced Research Associates
      • Corpus Christi, Texas, United States, 78412
        • Nueces County Women's Clinic dba Corpus Christi Women's Clinic an Elligo Health Research Site
      • Fort Worth, Texas, United States, 76104
        • Ventavia Research Group
      • Houston, Texas, United States, 77054
        • TMC Life Research, Inc.
      • Irving, Texas, United States, 75062
        • Cedar Health Research, LLC_Avacare West
      • Katy, Texas, United States, 77450
        • Medical Colleagues of Texas, LLP
    • Utah
      • Draper, Utah, United States, 84020
        • Physicians Research Options
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Tidewater Clinical Research Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
A qualitative in vitro test that amplifies and detects HR HPV DNA in cervical tissue samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Progression greater than or equal to (cervical intraepithelial neoplasia) CIN3
Time Frame: Baseline to 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease progression greater than or equal to cervical intraepithelial neoplasia (CIN2)
Time Frame: Baseline to 12 weeks
Diagnosis of greater than or equal to CIN2 (cervical intraepithelial neoplasia) is based on central pathology review panel histologic result.
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Molecular

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2021

Primary Completion (Actual)

June 16, 2022

Study Completion (Actual)

November 3, 2022

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V560-02-20S07-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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