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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14935

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 3, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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