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
Brief Title
Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens
Categories
Completion Date
Completion Date Type
Actual
Conditions
Cervical Neoplasms
Human Papillomavirus
Eligibility Criteria
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
* 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
Inclusion Criteria
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.
* 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.
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
21 Years
NCT Id
NCT02267876
Org Class
Industry
Org Full Name
Becton, Dickinson and Company
Org Study Id
BDS-USLHPV
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens
Primary Outcomes
Outcome Description
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.
Outcome Measure
Cumulative risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over three years in Human Papillomavirus (HPV) Positive Patients.
Outcome Time Frame
3 years
Outcome Description
Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk).
Outcome Measure
Absolute Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in Human Papillovirus (HPV) Positive Patients.
Outcome Time Frame
3 years
Outcome Description
The sensitivity and specificity of HPV primary screening algorithms for identifying ≥ CIN2 and ≥ CIN3 using genotyping and cytology will be calculated.
Outcome Measure
To evaluate different screening strategies using Human Papillovirus (HPV) results with 16/18/45 genotyping and cytology.
Outcome Time Frame
3 years
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
3 years
Outcome Measure
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.
Outcome Description
Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk).
Outcome Time Frame
3 years
Outcome Measure
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.
Outcome Description
The sensitivity and specificity of HPV primary screening algorithms for identifying ≥ CIN2 and ≥ CIN3 using genotyping and cytology will be calculated.
Outcome Time Frame
3 years
Outcome Measure
Evaluate Different Screening Strategies Using HPV Results with Genotyping (other than 16/18/45) and Cytology.
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Participants were selected from a baseline study BDS-USHPV, which included female healthy volunteers.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jessica Atrio
Investigator Email
jatrio@montefiore.org
Investigator Phone
Categories Mesh Debug
Prostate Cancer --- UROGENITAL NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Gynecologic Cancers --- UTERINE CERVICAL DISEASES
Gynecologic Cancers --- UTERINE DISEASES
MeSH Terms
UTERINE CERVICAL NEOPLASMS
UTERINE NEOPLASMS
GENITAL NEOPLASMS, FEMALE
UROGENITAL NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
UTERINE CERVICAL DISEASES
UTERINE DISEASES
GENITAL DISEASES, FEMALE
FEMALE UROGENITAL DISEASES
FEMALE UROGENITAL DISEASES AND PREGNANCY COMPLICATIONS
UROGENITAL DISEASES
GENITAL DISEASES
COLPOSCOPY
DIAGNOSTIC TECHNIQUES, OBSTETRICAL AND GYNECOLOGICAL
DIAGNOSTIC TECHNIQUES AND PROCEDURES
DIAGNOSIS
ENDOSCOPY
DIAGNOSTIC TECHNIQUES, SURGICAL
MINIMALLY INVASIVE SURGICAL PROCEDURES
SURGICAL PROCEDURES, OPERATIVE
OBSTETRIC SURGICAL PROCEDURES
GYNECOLOGIC SURGICAL PROCEDURES
UROGENITAL SURGICAL PROCEDURES