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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BD VIPER LT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BD HPV Assay on Viper LT | Device | The BD HPV specimen will be tested with the BD HPV Assay on the Viper LT instrument. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants were selected from a baseline study BDS-USHPV, which included female healthy volunteers.
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| Name | Affiliation | Role |
|---|---|---|
| Tobi Karchmer, MD | Becton, Dickinson and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| Mobile OB/GYN |
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| Colposcopy | Procedure | The colposcopy will be performed on subjects that have abnormal cytology. At the third year visit all subjects will have an exit colposcopy. |
|
| 3 years |
| 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 |
| 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 |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Women's Health Research of Arizona | Phoenix | Arizona | 85015 | United States |
| Quality of Life Medical & Research Center | Tucson | Arizona | 85712 | United States |
| Visions Clinical Research | Tucson | Arizona | 85712 | United States |
| Women's Health Care Research Corp. | San Diego | California | 92123 | United States |
| Blueskies Center for Women | Colorado Springs | Colorado | 80910 | United States |
| Health Awareness Inc. | Jupiter | Florida | 33458 | United States |
| Altus Research | Lake Worth | Florida | 33461 | United States |
| Segal Institute for Clinical Research | North Miami | Florida | 33161 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Comprehensive Clinical Trails, LLC | West Palm Beach | Florida | 33409 | United States |
| Medical Network for Education & Research | Decatur | Georgia | 30033 | United States |
| Fellows Research Alliance - Savannah | Savannah | Georgia | 31406 | United States |
| Women's Health Practice | Champaign | Illinois | 61820 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Four Rivers Clinical Research | Paducah | Kentucky | 42003 | United States |
| Louisiana State University | New Orleans | Louisiana | 70112 | United States |
| BD 54 Loveton | Sparks | Maryland | 21152 | United States |
| Saginaw Valley Medical Research | Saginaw | Michigan | 48604 | United States |
| Virtua Phoenix OB/GYN | Moorestown | New Jersey | 08057 | United States |
| Meridian Health / Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | United States |
| Quest Laboratories | Teterboro | New Jersey | 07608 | United States |
| TriCore | Albuquerque | New Mexico | 87102 | United States |
| Research Pathology Associates, LLC | Irvington | New York | 10533 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Eastern Carolina Women's Center | New Bern | North Carolina | 28562 | United States |
| Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| HWC Women's Research Center | Englewood | Ohio | 45322 | United States |
| Center for Women's Health of Lansdale | Lansdale | Pennsylvania | 19446 | United States |
| Clinical Research of Philadelphia | Philadelphia | Pennsylvania | 19114 | United States |
| Reading Health Physician Network | West Reading | Pennsylvania | 19611 | United States |
| Fellows Research Alliance - Bluffton | Bluffton | South Carolina | 29910 | United States |
| James T. Martin Jr. OB/GYN | North Charleston | South Carolina | 29406 | United States |
| Chattanooga Medical Research | Chattanooga | Tennessee | 37404 | United States |
| Center for Disease Detection, LLC | San Antonio | Texas | 78233 | United States |
| Physicians Research Options | Draper | Utah | 84020 | United States |
| Research Pathology Associates | Charlottesville | Virginia | 22901 | United States |
| Tidewater Clinical Research | Virginia Beach | Virginia | 23462 | United States |
| BioVision | Montreal | Quebec | H2V3J1 | Canada |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D003127 | Colposcopy |
| ID | Term |
|---|---|
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013513 | Obstetric Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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