HR-HPV Multi-site Opportunistic Screening in Liaoning, China

It is universally accepted that the persistent infection of high-risk human papillomavirus(HR-HPV) is the cause of cervical intraepithelial neoplasias and cancer. Some researches indicate that the virus load may relate the extent of the disease. The objective of the study is to detect the virus load of 14 types HR-HPV among the participants, using a new HPV DNA hybrid capture technology,sequentially find the diagnostic significance of virus load of HPV.

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer

Detailed Description

Cervical cancer is the most common malignancy in women, the persistent infection of high-risk human papillomavirus(HR-HPV) is the definite cause,especially the infection of human papillomavirus 16/human papillomavirus 18(HPV16/HPV18). Some researches indicate the virus load may relate the extent of the disease, but the sample capacity is not enough to receive a conclusive conclusion. And a specific quantity or a range of virus load which closely relates to cervical intraepithelial neoplasia 2(CIN2) or worse is not studied. The aim of the study is to prove the association between the virus load and development of cervical intraepithelial neoplasias by detecting 14 types HR-HPV, and find the specific quantitative value or the range to assist physician to diagnose.

A detect reagent named Dalton hybrid 3(DH3) is used in the study, the mechanism of which is HPV DNA hybrid capture technology, the experimental process include seven steps, denaturation, hybridization, the formation of DNA-RNA heterozygote, capture, detect, rinse panel, read data.

Study design: The organizations of the study contain ten hospitals in Liaoning province in China,patients accord with inclusion criteria(N=10000) sign informed consent and fill out a information form. Gynecologist collect cervical cell with sampling instrument. Detecting the virus load of HPV16/HPV18 and other 12 types HR-HPV, the positive result is cut-off ≥1.0pg/ml, HPV16/HPV18(+) need colposcopy. The abnormal result of colposcopy requires biopsy, the participant who has abnormal result of biopsy need operative treatment. Follow-up observation of all participants lasting 5 years are required.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Anshan, Liaoning, China
      • Cancer hospital of Anshan City
    • Chaoyang, Liaoning, China
      • The second hospital of Chaoyang City
    • Dalian, Liaoning, China
      • Dalian obstetrics and gynaecology hospital
    • Jinzhou, Liaoning, China
      • The First Affiliated Hospital of Jinzhou Medical University
    • Shenyang, Liaoning, China
      • The First Hospital of China Medical University
    • Yingkou, Liaoning, China
      • Women's and children's hospital of Yingkou City
  • Lioaning
    • Shenyang, Lioaning, China
      • Shenyang women's and children's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The patients who are voluntary to accept screening with sexual life between the age of 25 to 65 are the target population of the study.

The population who with uterectomy, cancer, other serious illness, physical examination are exclusive, the pregnant women are not exclusive.

Description

Inclusion Criteria:

The patients who are voluntary to accept screening with sexual life

Exclusion Criteria:

uterectomy, cancer, other serious illness, physical examination(pregnant women are not exclusive)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
case group; There is no intervention in case group.
control group; The control group as the contrast for case group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
virus load	virus load of 14 types HR-HPV	1 day

Collaborators and Investigators

• Sponsor: Min Wang
• Collaborators: First Hospital of China Medical University; The First People's Hospital of Jingzhou; The Second Affiliated Hospital of Dalian Medical University; Dalian Medical University; Shenyang women's and children's hostipal; Dandong women's and children's hostipal; The second hospital of Chaoyang City; Women's and children's hospital of Yingkou City; Cancer hospital of Anshan City; Hangzhou Dalton Biosciences,LtD
• Investigators: Study Director: Min Wang, Shengjing Hospital

Publications and helpful links

General Publications

• Snijders PJ, van den Brule AJ, Meijer CJ. The clinical relevance of human papillomavirus testing: relationship between analytical and clinical sensitivity. J Pathol. 2003 Sep;201(1):1-6. doi: 10.1002/path.1433.
• Vorsters A, Van Keer S, Biesmans S, Hens A, De Coster I, Goossens H, Ieven M, Van Damme P. Long-Term Follow-up of HPV Infection Using Urine and Cervical Quantitative HPV DNA Testing. Int J Mol Sci. 2016 May 17;17(5):750. doi: 10.3390/ijms17050750.
• Wakeham K, Kavanagh K, Cuschieri K, Millan D, Pollock KG, Bell S, Burton K, Reed NS, Graham SV. HPV status and favourable outcome in vulvar squamous cancer. Int J Cancer. 2017 Mar 1;140(5):1134-1146. doi: 10.1002/ijc.30523.
• Wang M, Hou B, Wang X, Han L, Shi Y, Zhang Y, Zhang L, Liu L, Jin F, Zhang Y. Diagnostic value of high-risk human papillomavirus viral load on cervical lesion assessment and ASCUS triage. Cancer Med. 2021 Apr;10(7):2482-2488. doi: 10.1002/cam4.3653. Epub 2021 Mar 7.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: May 20, 2017
• First Submitted That Met QC Criteria: June 4, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): January 3, 2019
• Last Update Submitted That Met QC Criteria: January 1, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: HR-HPV opportunistic screening; virus load; multi-site
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: LSBCIGO-1-DH3-2016-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No