search
Back to results

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

Primary Purpose

Human Papillomavirus

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alinity m HR HPV
Sponsored by
Abbott Molecular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Human Papillomavirus focused on measuring HPV, Virus, Cervical, Cancer, Oncology, Screening, tissue collection, biopsy

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Hospital
  • MedPharmics, LLC
  • Desert Bloom Family Medicine / West Valley Research Clinic, LLC
  • Quality of Life Medical & Research Centers, LLC
  • Visions Clinical Research
  • Northern California Research
  • Physicians' Research Options
  • Planned Parenthood of Southern New England
  • David I Lubetkin, MD, LLC
  • Health Awareness INC
  • Health Awareness, Inc.
  • Partners in Womens Health of Jupiter, LLC
  • Altus Research
  • South Florida Clinical Research
  • South Miami OB-GYN, Associates, LLC
  • Health Awareness, Inc.
  • Physician Care Clinical Research LLC
  • Joyce R. Miller, MD, LLC dba South Miami Womens Health an Elligo Health Research Site
  • Comprehensive Clinical Trials, LLC
  • Soapstone Center For Clinical Research
  • The Women's Clinic
  • Clinical Research Prime
  • Leavitt Women's Healthcare
  • Providea Health Partners, LLC an Elligo Health Research Site
  • Women's Health Advantage
  • Clinical Trials Management, LLC
  • MedPharmics, LLC
  • Newman Comprehensive Obgyn
  • MedPharmics, LLC
  • NECCR Fall River LLC
  • Valley Ob-Gyn Clinic, PC and Elligo Health Research Site
  • Saginaw Valley Medical Research Group
  • Planned Parenthood MN-ND-SD
  • MedPharmics
  • Meridian Clinical Research
  • Women's Clinic of Lincoln, PC
  • Dr. Nader and Associates
  • Rex Garn Mabey
  • Capital Health - Lawrence Ob-Gyn Associates PC
  • Carolina Institute for Clinical Research
  • Eastern Carolina Women's Center
  • Unified Women's Clinical Research -Raleigh
  • Unified Women's Clinical Research- Lyndhurst Clinical Research
  • Cleveland MacDonald Women's Hospital
  • Hilltop Obstetrics & Gynecology, Inc.
  • The Ohio State University Obstetrics and Gynecology Worthington
  • The Ohio State University Obstetrics and Gynecology Worthington
  • OB GYN Associates of Erie
  • VitaLink Research - Greenville
  • Tribe Clinical Research dba Mountain View Clinical Research
  • Medical Research Center of Memphis, LLC
  • Women's Health Texas, LLC (Elligo)
  • Hill Country OB/GYN Associates
  • Austin Area Obgyn, PLLC
  • Christina Sebestyen MD, P.A. dba OBGYN North
  • Nueces County Women's Clinic dba Corpus Christi Women's Clinic an Elligo Health Research Site
  • Advanced Research Associates
  • Ventavia Research Group
  • TMC Life Research, Inc.
  • Cedar Health Research, LLC_Avacare West
  • Medical Colleagues of Texas, LLP
  • Physicians Research Options
  • Tidewater Clinical Research Inc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alinity m HR HPV

Arm Description

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)].

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 5, 2021
Last Updated
November 16, 2022
Sponsor
Abbott Molecular
search

1. Study Identification

Unique Protocol Identification Number
NCT04746872
Brief Title
Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
Official Title
Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Molecular

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papillomavirus
Keywords
HPV, Virus, Cervical, Cancer, Oncology, Screening, tissue collection, biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alinity m HR HPV
Arm Type
Experimental
Arm Description
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)].
Intervention Type
Device
Intervention Name(s)
Alinity m HR HPV
Intervention Description
Alinity m HR HPV
Primary Outcome Measure Information:
Title
Disease Progression greater than or equal to (cervical intraepithelial neoplasia) CIN3
Description
Diagnosis of greater than or equal to CIN3 (cervical intraepithelial neoplasia) is based on central pathology review panel histologic result.
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Disease progression greater than or equal to cervical intraepithelial neoplasia (CIN2)
Description
Diagnosis of greater than or equal to CIN2 (cervical intraepithelial neoplasia) is based on central pathology review panel histologic result.
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The participant must be biologically female.
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Alabama at Birmingham Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
MedPharmics, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Desert Bloom Family Medicine / West Valley Research Clinic, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85031
Country
United States
Facility Name
Quality of Life Medical & Research Centers, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Visions Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Physicians' Research Options
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Planned Parenthood of Southern New England
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
David I Lubetkin, MD, LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Health Awareness INC
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Health Awareness, Inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Partners in Womens Health of Jupiter, LLC
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Altus Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33416
Country
United States
Facility Name
South Florida Clinical Research
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
South Miami OB-GYN, Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Health Awareness, Inc.
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Physician Care Clinical Research LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Joyce R. Miller, MD, LLC dba South Miami Womens Health an Elligo Health Research Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Comprehensive Clinical Trials, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Soapstone Center For Clinical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
The Women's Clinic
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Clinical Research Prime
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Leavitt Women's Healthcare
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Providea Health Partners, LLC an Elligo Health Research Site
City
Mokena
State/Province
Illinois
ZIP/Postal Code
60448
Country
United States
Facility Name
Women's Health Advantage
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Clinical Trials Management, LLC
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
MedPharmics, LLC
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Newman Comprehensive Obgyn
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
MedPharmics, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
NECCR Fall River LLC
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Valley Ob-Gyn Clinic, PC and Elligo Health Research Site
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Saginaw Valley Medical Research Group
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Planned Parenthood MN-ND-SD
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
MedPharmics
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Facility Name
Meridian Clinical Research
City
Hastings
State/Province
Nebraska
ZIP/Postal Code
68901
Country
United States
Facility Name
Women's Clinic of Lincoln, PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Dr. Nader and Associates
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Facility Name
Rex Garn Mabey
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Capital Health - Lawrence Ob-Gyn Associates PC
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Carolina Institute for Clinical Research
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Eastern Carolina Women's Center
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Unified Women's Clinical Research -Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27606
Country
United States
Facility Name
Unified Women's Clinical Research- Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cleveland MacDonald Women's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Hilltop Obstetrics & Gynecology, Inc.
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
The Ohio State University Obstetrics and Gynecology Worthington
City
Worthington
State/Province
Ohio
ZIP/Postal Code
43085-2688
Country
United States
Facility Name
The Ohio State University Obstetrics and Gynecology Worthington
City
Worthington
State/Province
Ohio
ZIP/Postal Code
43085
Country
United States
Facility Name
OB GYN Associates of Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507
Country
United States
Facility Name
VitaLink Research - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Tribe Clinical Research dba Mountain View Clinical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Medical Research Center of Memphis, LLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Women's Health Texas, LLC (Elligo)
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Hill Country OB/GYN Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78748
Country
United States
Facility Name
Austin Area Obgyn, PLLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Christina Sebestyen MD, P.A. dba OBGYN North
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Nueces County Women's Clinic dba Corpus Christi Women's Clinic an Elligo Health Research Site
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
Advanced Research Associates
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Ventavia Research Group
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
TMC Life Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Cedar Health Research, LLC_Avacare West
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Medical Colleagues of Texas, LLP
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Physicians Research Options
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Tidewater Clinical Research Inc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs