Cervical Neoplasms, Human Papillomavirus
Conditions
Brief summary
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
Interventions
DEVICEBD HPV Assay on Viper LT
The BD HPV specimen will be tested with the BD HPV Assay on the Viper LT instrument.
PROCEDUREColposcopy
The colposcopy will be performed on subjects that have abnormal cytology. At the third year visit all subjects will have an exit colposcopy.
Sponsors
Becton, Dickinson and Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over three years in Human Papillomavirus (HPV) Positive Patients. | 3 years | 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. |
| Absolute Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in Human Papillovirus (HPV) Positive Patients. | 3 years | Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk). |
| To evaluate different screening strategies using Human Papillovirus (HPV) results with 16/18/45 genotyping and cytology. | 3 years | The sensitivity and specificity of HPV primary screening algorithms for identifying ≥ CIN2 and ≥ CIN3 using genotyping and cytology will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 3 years | 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. |
| 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. | 3 years | Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk). |
| Evaluate Different Screening Strategies Using HPV Results with Genotyping (other than 16/18/45) and Cytology. | 3 years | The sensitivity and specificity of HPV primary screening algorithms for identifying ≥ CIN2 and ≥ CIN3 using genotyping and cytology will be calculated. |
Countries
Canada, United States
Outcome results
None listed