Human Papillomavirus Clinical Trial
Official title:
Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
| Verified date | February 2024 |
| Source | Abbott Molecular |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 14935 |
| Est. completion date | November 3, 2022 |
| Est. primary completion date | June 16, 2022 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 25 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Austin Area Obgyn, PLLC | Austin | Texas |
| United States | Christina Sebestyen MD, P.A. dba OBGYN North | Austin | Texas |
| United States | Hill Country OB/GYN Associates | Austin | Texas |
| United States | Women's Health Texas, LLC (Elligo) | Austin | Texas |
| United States | University of Alabama at Birmingham Hospital | Birmingham | Alabama |
| United States | David I Lubetkin, MD, LLC | Boca Raton | Florida |
| United States | The Women's Clinic | Boise | Idaho |
| United States | Cleveland MacDonald Women's Hospital | Cleveland | Ohio |
| United States | Advanced Research Associates | Corpus Christi | Texas |
| United States | Nueces County Women's Clinic dba Corpus Christi Women's Clinic an Elligo Health Research Site | Corpus Christi | Texas |
| United States | Clinical Trials Management, LLC | Covington | Louisiana |
| United States | MedPharmics, LLC | Covington | Louisiana |
| United States | Newman Comprehensive Obgyn | Covington | Louisiana |
| United States | Soapstone Center For Clinical Research | Decatur | Georgia |
| United States | Physicians Research Options | Draper | Utah |
| United States | OB GYN Associates of Erie | Erie | Pennsylvania |
| United States | NECCR Fall River LLC | Fall River | Massachusetts |
| United States | Carolina Institute for Clinical Research | Fayetteville | North Carolina |
| United States | Women's Health Advantage | Fort Wayne | Indiana |
| United States | Ventavia Research Group | Fort Worth | Texas |
| United States | Hilltop Obstetrics & Gynecology, Inc. | Franklin | Ohio |
| United States | VitaLink Research - Greenville | Greenville | South Carolina |
| United States | Tribe Clinical Research dba Mountain View Clinical Research | Greer | South Carolina |
| United States | MedPharmics | Gulfport | Mississippi |
| United States | Meridian Clinical Research | Hastings | Nebraska |
| United States | TMC Life Research, Inc. | Houston | Texas |
| United States | Clinical Research Prime | Idaho Falls | Idaho |
| United States | Leavitt Women's Healthcare | Idaho Falls | Idaho |
| United States | Cedar Health Research, LLC_Avacare West | Irving | Texas |
| United States | Health Awareness INC | Jupiter | Florida |
| United States | Health Awareness, Inc. | Jupiter | Florida |
| United States | Partners in Womens Health of Jupiter, LLC | Jupiter | Florida |
| United States | Medical Colleagues of Texas, LLP | Katy | Texas |
| United States | Altus Research | Lake Worth | Florida |
| United States | Physicians' Research Options | Lakewood | Colorado |
| United States | Dr. Nader and Associates | Las Vegas | Nevada |
| United States | Rex Garn Mabey | Las Vegas | Nevada |
| United States | Capital Health - Lawrence Ob-Gyn Associates PC | Lawrenceville | New Jersey |
| United States | Women's Clinic of Lincoln, PC | Lincoln | Nebraska |
| United States | South Florida Clinical Research | Margate | Florida |
| United States | Medical Research Center of Memphis, LLC | Memphis | Tennessee |
| United States | MedPharmics, LLC | Metairie | Louisiana |
| United States | South Miami OB-GYN, Associates, LLC | Miami | Florida |
| United States | Providea Health Partners, LLC an Elligo Health Research Site | Mokena | Illinois |
| United States | Eastern Carolina Women's Center | New Bern | North Carolina |
| United States | Planned Parenthood of Southern New England | New Haven | Connecticut |
| United States | Tidewater Clinical Research Inc | Norfolk | Virginia |
| United States | Desert Bloom Family Medicine / West Valley Research Clinic, LLC | Phoenix | Arizona |
| United States | MedPharmics, LLC | Phoenix | Arizona |
| United States | Health Awareness, Inc. | Port Saint Lucie | Florida |
| United States | Unified Women's Clinical Research -Raleigh | Raleigh | North Carolina |
| United States | Northern California Research | Sacramento | California |
| United States | Saginaw Valley Medical Research Group | Saginaw | Michigan |
| United States | Valley Ob-Gyn Clinic, PC and Elligo Health Research Site | Saginaw | Michigan |
| United States | Planned Parenthood MN-ND-SD | Saint Paul | Minnesota |
| United States | Physician Care Clinical Research LLC | Sarasota | Florida |
| United States | Joyce R. Miller, MD, LLC dba South Miami Womens Health an Elligo Health Research Site | South Miami | Florida |
| United States | Quality of Life Medical & Research Centers, LLC | Tucson | Arizona |
| United States | Visions Clinical Research | Tucson | Arizona |
| United States | Comprehensive Clinical Trials, LLC | West Palm Beach | Florida |
| United States | Unified Women's Clinical Research- Lyndhurst Clinical Research | Winston-Salem | North Carolina |
| United States | The Ohio State University Obstetrics and Gynecology Worthington | Worthington | Ohio |
| United States | The Ohio State University Obstetrics and Gynecology Worthington | Worthington | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Molecular |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Baseline to 12 weeks | |
| Secondary | 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. | Baseline to 12 weeks |
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