Human PapillomavirusNCT04746872
Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
An observational study of Human Papillomavirus, run by Abbott Molecular at 63 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Human Papillomavirus
- What is being tested?
- Alinity m HR HPV
- How many people
- 14,935 participants
- Where
- 63 sitesUnited States
- Study dates
- 16 Feb 2021to 3 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Woman who are ≥25 years of age who are high risk humpapillomarius (HPV).
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
63 sites in 1 country.
63 sites in 1 country
United States63 sites
Women's Health Texas, LLC (Elligo)
Austin, Texas, 78705
Hill Country OB/GYN Associates
Austin, Texas, 78748
Austin Area Obgyn, PLLC
Austin, Texas, 78758
Christina Sebestyen MD, P.A. dba OBGYN North
Austin, Texas, 78758
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35233
David I Lubetkin, MD, LLC
Boca Raton, Florida, 33486
The Women's Clinic
Boise, Idaho, 83712
Cleveland MacDonald Women's Hospital
Cleveland, Ohio, 44106
Nueces County Women's Clinic dba Corpus Christi Women's Clinic an Elligo Health Research Site
Corpus Christi, Texas, 78412
Advanced Research Associates
Corpus Christi, Texas, 78414
Clinical Trials Management, LLC
Covington, Louisiana, 70433
MedPharmics, LLC
Covington, Louisiana, 70433
Newman Comprehensive Obgyn
Covington, Louisiana, 70433
Soapstone Center For Clinical Research
Decatur, Georgia, 30034
Physicians Research Options
Draper, Utah, 84020
OB GYN Associates of Erie
Erie, Pennsylvania, 16507
NECCR Fall River LLC
Fall River, Massachusetts, 02720
Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28304
Women's Health Advantage
Fort Wayne, Indiana, 46825
Ventavia Research Group
Fort Worth, Texas, 76104
Hilltop Obstetrics & Gynecology, Inc.
Franklin, Ohio, 45005
VitaLink Research - Greenville
Greenville, South Carolina, 29615
Tribe Clinical Research dba Mountain View Clinical Research
Greer, South Carolina, 29651
MedPharmics
Gulfport, Mississippi, 39503
Meridian Clinical Research
Hastings, Nebraska, 68901
TMC Life Research, Inc.
Houston, Texas, 77054
Clinical Research Prime
Idaho Falls, Idaho, 83404
Leavitt Women's Healthcare
Idaho Falls, Idaho, 83404
Cedar Health Research, LLC_Avacare West
Irving, Texas, 75062
Health Awareness INC
Jupiter, Florida, 33458
Health Awareness, Inc.
Jupiter, Florida, 33458
Partners in Womens Health of Jupiter, LLC
Jupiter, Florida, 33458
Medical Colleagues of Texas, LLP
Katy, Texas, 77450
Altus Research
Lake Worth, Florida, 33416
Physicians' Research Options
Lakewood, Colorado, 80228
Dr. Nader and Associates
Las Vegas, Nevada, 89030
Rex Garn Mabey
Las Vegas, Nevada, 89128
Capital Health - Lawrence Ob-Gyn Associates PC
Lawrenceville, New Jersey, 08648
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, 68510
South Florida Clinical Research
Margate, Florida, 33063
Medical Research Center of Memphis, LLC
Memphis, Tennessee, 38120
MedPharmics, LLC
Metairie, Louisiana, 70006
South Miami OB-GYN, Associates, LLC
Miami, Florida, 33143
Providea Health Partners, LLC an Elligo Health Research Site
Mokena, Illinois, 60448
Eastern Carolina Women's Center
New Bern, North Carolina, 28562
Planned Parenthood of Southern New England
New Haven, Connecticut, 06511
Tidewater Clinical Research Inc
Norfolk, Virginia, 23502
MedPharmics, LLC
Phoenix, Arizona, 85012
Desert Bloom Family Medicine / West Valley Research Clinic, LLC
Phoenix, Arizona, 85031
Health Awareness, Inc.
Port Saint Lucie, Florida, 34952
Unified Women's Clinical Research -Raleigh
Raleigh, North Carolina, 27606
Northern California Research
Sacramento, California, 95821
Valley Ob-Gyn Clinic, PC and Elligo Health Research Site
Saginaw, Michigan, 48602
Saginaw Valley Medical Research Group
Saginaw, Michigan, 48604
Planned Parenthood MN-ND-SD
Saint Paul, Minnesota, 55114
Physician Care Clinical Research LLC
Sarasota, Florida, 34239
Joyce R. Miller, MD, LLC dba South Miami Womens Health an Elligo Health Research Site
South Miami, Florida, 33143
Quality of Life Medical & Research Centers, LLC
Tucson, Arizona, 85712
Visions Clinical Research
Tucson, Arizona, 85712
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
Unified Women's Clinical Research- Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
The Ohio State University Obstetrics and Gynecology Worthington
Worthington, Ohio, 43085-2688
The Ohio State University Obstetrics and Gynecology Worthington
Worthington, Ohio, 43085
About this study
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
- Being tested
- Alinity m HR HPV
- Keywords
- HPV, Virus, Cervical, Cancer, Oncology, Screening, tissue collection, biopsy
- Medical subject headings
- Virus Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alinity m HR HPVDiagnostic test
A qualitative in vitro test that amplifies and detects HR HPV DNA in cervical tissue samples.
| Study group | Role | What they receive |
|---|---|---|
| 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)]. Receives: Diagnostic Test: Alinity m HR HPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 weeks
Secondary outcomes (1)
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.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start16 Feb 2021
- Primary completion16 Jun 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human PapillomavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 14,935 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Molecular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746872
- Sponsor's protocol ID
- V560-02-20S07-01
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2021
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT04746872
- Acronym / sponsor ID
- V560-02-20S07-01
- Conditions
- Human Papillomavirus
- Keywords
- HPV, Virus, Cervical, Cancer, Oncology, Screening, tissue collection, biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,935 participants (actual)
- Lead sponsor
- Abbott MolecularIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alinity m HR HPV | – | Diagnostic Test: Alinity m HR HPVThe 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)]. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Woman who are ≥25 years of age who are high risk humpapillomarius (HPV).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alinity m HR HPVA qualitative in vitro test that amplifies and detects HR HPV DNA in cervical tissue samples. | Diagnostic test | Alinity m HR HPV |
Primary outcome
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.
1 secondary outcome
Disease progression greater than or equal to cervical intraepithelial neoplasia (CIN2)
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
Related trials for Human Papillomavirus
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
Active, not recruitingPhase 4
Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial
Human Papillomavirus-Related Cervical Carcinoma
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Not yet recruitingObservational study
C-3002: Enhancing Cervical Cancer Screening Access and Follow-up Care at 'CASCADE' Clinical Sites in the United States
Human Immunodeficiency Virus (HIV), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
63 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus, run by Abbott Molecular at 63 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Progression greater than or equal to (cervical intraepithelial neoplasia) CIN3 (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024; AzTrials last refreshed its copy on 26 Oct 2026.