Clinical Trial for Registration of HPV Nucleic Acid Genotyping Assay Kit

NCT04461678 | Completed

• 1 other identifier: BDS-19CNHPV
• Study Type: interventional
• Target: 12,230
• Locations: 1 country
• Sites: 5

Brief Summary

The objective of this study is to verify the clinical effectiveness of HPV Genotyping Nucleic Acid Assay Kit. This is a multi-center clinical study involving at least three study centers, each with screening sites. The protocol describes two study phases: Phase I is a baseline study of the screened population and ASCUS referral population (if necessary), the data of which will be submitted after the baseline study is completed; Phase II is a three-year follow-up study of the screened population, the data of which will be submitted again after the follow-up is completed.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (4)

• Verification of the accuracy of nucleic acid assay

  The results of HPV Assay of test product and reference product

  12 weeks

• PLR and NLR in ASCUS population

  Clinical sensitivity (Sn), clinical specificity (Sp), positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR) and negative likelihood ratio (NLR) of carcinogenic HPV+ in case of ≥CIN2.

  12 weeks

• HPV risk of ≥ CIN2 in NILM 30+ population

  1. absolute risk and 95%CI of HPV+, HPV 16 / 18/45 +, HPV31 / 33\_58 / 52; HPV51 / 35\_39\_68 / 56\_59\_66 + and HPV- in case of ≥ CIN2 2. Relative risk and 95%CI of HPV+ and HPV- in case of ≥ CIN2 3. Relative risk and 95%CI of HPV 16 / 18/45 and HPV- in case of ≥ CIN2 4. Relative risk and 95%CI of HPV 31 / 33\_58 / 52 and HPV- in case of ≥ CIN2 5. Relative risk and 95%CI of HPV 51, 35 / 39 / 68, 56 / 59/66 and HPV- in case of ≥ CIN2 6. Relative risk and 95%CI of HPV 16 / 18/45 + and HPV 31 / 33\_58 / 52 + in case of ≥ CIN2 7. Relative risk and 95%CI of HPV 16 / 18/45 + and HPV 51, 35 / 39 / 68, 56 / 59/66 + in case of ≥ CIN2 8. Relative risk and 95%CI of HPV 31 / 33\_58 / 52 + and HPV 51, 35 / 39 / 68, 56 / 59/66 + in case of ≥ CIN2

  3 years

• HPV risk of ≥ CIN2 in Primary screening

  1. Absolute risk and 95%CI of NILM, HPV-, HPV +, HPV16 / 18/45 +, HPV 31 / 33\_58 / 52 +, HPV 51, 35 / 39 / 68, 56 / 59/66 + and HPV in case of ≥ CIN2 2. Relative risk and 95%CI of NILM and HPV- in case of ≥ CIN2 3. Relative risk and 95%CI of HPV+ and HPV- in case of ≥ CIN2 4. Relative risk and 95%CI of HPV 16 / 18/45+ and HPV- in case of ≥ CIN2 5. Relative risk and 95%CI of HPV 31 / 33\_58 / 52 and HPV- in case of ≥ CIN2 6. Relative risk and 95%CI of HPV 51, 35 / 39 / 68, 56 / 59/66 and HPV- in case of ≥ CIN2 7. Relative risk and 95%CI of HPV 16 / 18/45 + and HPV 31 / 33\_58 / 52 + in case of ≥ CIN2 8. Relative risk and 95%CI of HPV 16 / 18/45 + and HPV 51, 35 / 39 / 68, 56 / 59/66 + in case of ≥ CIN2 9. Relative risk and 95%CI of HPV 31 / 33\_58 / 52 + and HPV 51, 35 / 39 / 68, 56 / 59/66 + in case of ≥ CIN2

  3 years

Study Arms (1)

Screening population and ASCUS referral population

EXPERIMENTAL

The screening population: Two cervical cytology samples will be collected from each subject. The 1st tube of SurePath liquid-based cytology sample is used for cytology test and BD Onclarity Assay HPV detection. Subjects with cytology test results ≥ ASCUS or positive HPV test results will be suggested to return for baseline colposcopy within approximately 12 weeks. In case of visible lesions under colposcopy, a biopsy of tissues at the site of the lesion will be performed; in case of no visible lesions, randombiopsy and/or ECC will be performed. Patients with histopathological results ≥ CIN2 will completed the study. ASCUS referral population: Female subjects with an ASCUS cytology result will be recalled undergo colposcopy, the remaining samples for cytology test collected prior to enrollment will be used for BD Onclarity Assay HPV test.

Diagnostic Test: HPV Genotyping Nucleic Acid Assay Kit

Interventions

HPV Genotyping Nucleic Acid Assay Kit DIAGNOSTIC_TEST

The total sample size of screening population is approximately 12,000 cases (all females ≥ 21 years of age). Two cervical cytology samples will be collected from each subject with a tube of SurePath sample followed by a tube of PreservCyt sample. The 1st tube of SurePath liquid-based cytology sample is used for cytology test and BD Onclarity Assay HPV detection. Subjects with cytology test results ≥ ASCUS or positive HPV test results will be suggested to return for baseline colposcopy within approximately 12 weeks.

Screening population and ASCUS referral population

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects ≥ 21 of age and \< 65 of age
• Subjects who have signed the inform consent form

You may not qualify if:

• Pregnant subjects
• Subjects who have had cervical cytology samples taken in the last 12 months
• Subjects who have previously undergone a total hysterectomy
• Subjects who have previously undergone cone resection, LEEP, cervical laser surgery, cervical cryosurgery or uterine ablation within 3 years
• Subjects who are participating in other clinical trials of cervical disease diagnostic products

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (5)

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Obstetrics&Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

Heping Hospital Affilated to Changzhi Medical College

Changzhi, Shanxi, China

Location

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Shaokai Zhang

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 8, 2020
• Study Start: August 23, 2020
• Primary Completion: August 26, 2024
• Study Completion: August 26, 2024
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)