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Completed

NCT Number: NCT02267876

Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens

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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Key information

Conditions

CERVICAL NEOPLASMS Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Human Papillomavirus Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

BioVision, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BD HPV Assay on Viper LT

Device

The BD HPV specimen will be tested with the BD HPV Assay on the Viper LT instrument.

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.

Primary outcomes

  1. Cumulative risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over three years in Human Papillomavirus (HPV) Positive Patients.

    Time frame: 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.

  2. Absolute Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in Human Papillovirus (HPV) Positive Patients.

    Time frame: 3 years

    Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk).

  3. To evaluate different screening strategies using Human Papillovirus (HPV) results with 16/18/45 genotyping and cytology.

    Time frame: 3 years

    The sensitivity and specificity of HPV primary screening algorithms for identifying ≥ CIN2 and ≥ CIN3 using genotyping and cytology will be calculated.

Secondary outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: 3 years

    Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk).

  3. Evaluate Different Screening Strategies Using HPV Results with Genotyping (other than 16/18/45) and Cytology.

    Time frame: 3 years

    The sensitivity and specificity of HPV primary screening algorithms for identifying ≥ CIN2 and ≥ CIN3 using genotyping and cytology will be calculated.

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Oct 20, 2014
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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