Clinical trial NCT03178136: HR-HPV Multi-site Opportunistic Screening in Liaoning, China
Official title: HR-HPV Multi-site Opportunistic Screening in Liaoning, China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Keywords: HR-HPV opportunistic screening
virus load
multi-site
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
Collaborators: name: First Hospital of China Medical University
name: Shenyang women's and children's hostipal
name: Dalian Medical University
name: The Second Affiliated Hospital of Dalian Medical University
name: Dandong women's and children's hostipal
name: The First People's Hospital of Jingzhou
name: The second hospital of Chaoyang City
name: Women's and children's hospital of Yingkou City
name: Cancer hospital of Anshan City
name: Hangzhou Dalton Biosciences,LtD
First posted: 2017-06-06
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: virus load
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Anshan
country: China
facility: Cancer hospital of Anshan City
state: Liaoning
city: Chaoyang
country: China
facility: The second hospital of Chaoyang City
state: Liaoning
city: Dalian
country: China
facility: Dalian obstetrics and gynaecology hospital
state: Liaoning
city: Jinzhou
country: China
facility: The first affiliated hospital of Jinzhou Medical University
state: Liaoning
city: Shenyang
country: China
facility: The first hospital of China Medical University
state: Liaoning
city: Yingkou
country: China
facility: Women's and children's hospital of Yingkou City
state: Liaoning
city: Shenyang
country: China
facility: Shenyang women's and children's hospital
state: Lioaning
Study officials:
affiliation: Shengjing Hospital
name: Min Wang
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.