Human Papillomavirus Clinical Trial
Official title:
Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens
NCT number | NCT02267876 |
Other study ID # | BDS-USLHPV |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | May 2019 |
Verified date | February 2021 |
Source | Becton, Dickinson and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of the study is to assess the cumulative disease detection of greater than or equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV status and cytology status from the BDS-USHPV baseline results
Status | Completed |
Enrollment | 6730 |
Est. completion date | May 2019 |
Est. primary completion date | December 12, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Subject enrolled into the protocol BDS-USHPV and identified as eligible for the longitudinal protocol • Subjects enrolled into protocol BDS-USHPV with a baseline colposcopy and biopsy procedure and not treated. Exclusion Criteria: - Subjects with prior complete or partial hysterectomy involving removal of the cervix - Subjects on whom conization, LEEP, cervical laser surgery, or cryosurgery has been performed since enrollment into the BDS-USHPV study - Year 3 visit can not exceed 3 years and 6 months from the baseline visit |
Country | Name | City | State |
---|---|---|---|
Canada | BioVision | Montréal | Quebec |
United States | TriCore | Albuquerque | New Mexico |
United States | University of Alabama | Birmingham | Alabama |
United States | Fellows Research Alliance - Bluffton | Bluffton | South Carolina |
United States | Montefiore Medical Center | Bronx | New York |
United States | Women's Health Practice | Champaign | Illinois |
United States | Research Pathology Associates | Charlottesville | Virginia |
United States | Chattanooga Medical Research | Chattanooga | Tennessee |
United States | Blueskies Center for Women | Colorado Springs | Colorado |
United States | Medical Network for Education & Research | Decatur | Georgia |
United States | Physicians Research Options | Draper | Utah |
United States | HWC Women's Research Center | Englewood | Ohio |
United States | Indiana University | Indianapolis | Indiana |
United States | Research Pathology Associates, LLC | Irvington | New York |
United States | Health Awareness Inc. | Jupiter | Florida |
United States | Altus Research | Lake Worth | Florida |
United States | Center for Women's Health of Lansdale | Lansdale | Pennsylvania |
United States | Mobile OB/GYN | Mobile | Alabama |
United States | Virtua Phoenix OB/GYN | Moorestown | New Jersey |
United States | Meridian Health / Jersey Shore University Medical Center | Neptune | New Jersey |
United States | Eastern Carolina Women's Center | New Bern | North Carolina |
United States | Louisiana State University | New Orleans | Louisiana |
United States | James T. Martin Jr. OB/GYN | North Charleston | South Carolina |
United States | Segal Institute for Clinical Research | North Miami | Florida |
United States | Four Rivers Clinical Research | Paducah | Kentucky |
United States | Clinical Research of Philadelphia | Philadelphia | Pennsylvania |
United States | Women's Health Research of Arizona | Phoenix | Arizona |
United States | Saginaw Valley Medical Research | Saginaw | Michigan |
United States | Center for Disease Detection, LLC | San Antonio | Texas |
United States | Women's Health Care Research Corp. | San Diego | California |
United States | Fellows Research Alliance - Savannah | Savannah | Georgia |
United States | Miami Research Associates | South Miami | Florida |
United States | BD 54 Loveton | Sparks | Maryland |
United States | Quest Laboratories | Teterboro | New Jersey |
United States | Quality of Life Medical & Research Center | Tucson | Arizona |
United States | Visions Clinical Research | Tucson | Arizona |
United States | Tidewater Clinical Research | Virginia Beach | Virginia |
United States | Comprehensive Clinical Trails, LLC | West Palm Beach | Florida |
United States | Reading Health Physician Network | West Reading | Pennsylvania |
United States | Lyndhurst Clinical Research | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Becton, Dickinson and Company |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over three years in Human Papillomavirus (HPV) Positive Patients. | Cumulative risk is a measure of the total risk that a certain event will happen during a given period of time. In this longitudinal study, it refers to the risk of developing >=CIN2 or >=CIN3 in subjects over a three year period using the subjects' HPV status at baseline versus cytology status at baseline. | 3 years | |
Primary | Absolute Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in Human Papillovirus (HPV) Positive Patients. | Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk). | 3 years | |
Primary | To evaluate different screening strategies using Human Papillovirus (HPV) results with 16/18/45 genotyping and cytology. | The sensitivity and specificity of HPV primary screening algorithms for identifying = CIN2 and = CIN3 using genotyping and cytology will be calculated. | 3 years | |
Secondary | Cumulative Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in NILM (Negative for Intraepithelial lesion or malignancy) cytology and Human Papillovirus (HPV) Negative Patients. | Cumulative risk is a measure of the total risk that a certain event will happen during a given period of time. In this longitudinal study, it refers to the risk of developing >=CIN2 or >=CIN3 over a three year period for the population of women negative for intraepithelial lesions or malignancy (NILM) cytology and with Human Papillovirus (HPV) negative results. | 3 years | |
Secondary | Absolute Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in NILM (Negative for Intraepithelial Lesion or Malignancy) cytology and Human Papillomavirus (HPV) Negative Patients. | Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk). | 3 years | |
Secondary | Evaluate Different Screening Strategies Using HPV Results with Genotyping (other than 16/18/45) and Cytology. | The sensitivity and specificity of HPV primary screening algorithms for identifying = CIN2 and = CIN3 using genotyping and cytology will be calculated. | 3 years |
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