Clinical trial NCT04746872: 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: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus
Keywords: HPV
Virus
Cervical
Cancer
Oncology
Screening
tissue collection
biopsy
Lead sponsor: Abbott Molecular
Sponsor class: INDUSTRY
First posted: 2021-02-10
Enrollment: 14935
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Woman who are ≥25 years of age who are high risk humpapillomarius (HPV).

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.


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

Primary outcomes:
measure: Disease Progression greater than or equal to (cervical intraepithelial neoplasia) CIN3
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Disease progression greater than or equal to cervical intraepithelial neoplasia (CIN2)
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Hospital
state: Alabama
city: Phoenix
country: United States
facility: MedPharmics, LLC
state: Arizona
city: Phoenix
country: United States
facility: Desert Bloom Family Medicine / West Valley Research Clinic, LLC
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical & Research Centers, LLC
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research
state: Arizona
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: Lakewood
country: United States
facility: Physicians' Research Options
state: Colorado
city: New Haven
country: United States
facility: Planned Parenthood of Southern New England
state: Connecticut
city: Boca Raton
country: United States
facility: David I Lubetkin, MD, LLC
state: Florida
city: Jupiter
country: United States
facility: Health Awareness INC
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Jupiter
country: United States
facility: Partners in Womens Health of Jupiter, LLC
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Margate
country: United States
facility: South Florida Clinical Research
state: Florida
city: Miami
country: United States
facility: South Miami OB-GYN, Associates, LLC
state: Florida
city: Port Saint Lucie
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clinical Research LLC
state: Florida
city: South Miami
country: United States
facility: Joyce R. Miller, MD, LLC dba South Miami Womens Health an Elligo Health Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: Decatur
country: United States
facility: Soapstone Center For Clinical Research
state: Georgia
city: Boise
country: United States
facility: The Women's Clinic
state: Idaho
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Idaho Falls
country: United States
facility: Leavitt Women's Healthcare
state: Idaho
city: Mokena
country: United States
facility: Providea Health Partners, LLC an Elligo Health Research Site
state: Illinois
city: Fort Wayne
country: United States
facility: Women's Health Advantage
state: Indiana
city: Covington
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: Covington
country: United States
facility: MedPharmics, LLC
state: Louisiana
city: Covington
country: United States
facility: Newman Comprehensive Obgyn
state: Louisiana
city: Metairie
country: United States
facility: MedPharmics, LLC
state: Louisiana
city: Fall River
country: United States
facility: NECCR Fall River LLC
state: Massachusetts
city: Saginaw
country: United States
facility: Valley Ob-Gyn Clinic, PC and Elligo Health Research Site
state: Michigan
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group
state: Michigan
city: Saint Paul
country: United States
facility: Planned Parenthood MN-ND-SD
state: Minnesota
city: Gulfport
country: United States
facility: MedPharmics
state: Mississippi
city: Hastings
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, PC
state: Nebraska
city: Las Vegas
country: United States
facility: Dr. Nader and Associates
state: Nevada
city: Las Vegas
country: United States
facility: Rex Garn Mabey
state: Nevada
city: Lawrenceville
country: United States
facility: Capital Health - Lawrence Ob-Gyn Associates PC
state: New Jersey
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Raleigh
country: United States
facility: Unified Women's Clinical Research -Raleigh
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Research- Lyndhurst Clinical Research
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland MacDonald Women's Hospital
state: Ohio
city: Franklin
country: United States
facility: Hilltop Obstetrics & Gynecology, Inc.
state: Ohio
city: Worthington
country: United States
facility: The Ohio State University Obstetrics and Gynecology Worthington
state: Ohio
city: Worthington
country: United States
facility: The Ohio State University Obstetrics and Gynecology Worthington
state: Ohio
city: Erie
country: United States
facility: OB GYN Associates of Erie
state: Pennsylvania
city: Greenville
country: United States
facility: VitaLink Research - Greenville
state: South Carolina
city: Greer
country: United States
facility: Tribe Clinical Research dba Mountain View Clinical Research
state: South Carolina
city: Memphis
country: United States
facility: Medical Research Center of Memphis, LLC
state: Tennessee
city: Austin
country: United States
facility: Women's Health Texas, LLC (Elligo)
state: Texas
city: Austin
country: United States
facility: Hill Country OB/GYN Associates
state: Texas
city: Austin
country: United States
facility: Austin Area Obgyn, PLLC
state: Texas
city: Austin
country: United States
facility: Christina Sebestyen MD, P.A. dba OBGYN North
state: Texas
city: Corpus Christi
country: United States
facility: Nueces County Women's Clinic dba Corpus Christi Women's Clinic an Elligo Health Research Site
state: Texas
city: Corpus Christi
country: United States
facility: Advanced Research Associates
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group
state: Texas
city: Houston
country: United States
facility: TMC Life Research, Inc.
state: Texas
city: Irving
country: United States
facility: Cedar Health Research, LLC_Avacare West
state: Texas
city: Katy
country: United States
facility: Medical Colleagues of Texas, LLP
state: Texas
city: Draper
country: United States
facility: Physicians Research Options
state: Utah
city: Norfolk
country: United States
facility: Tidewater Clinical Research Inc
state: Virginia
Study officials:
References: