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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03178136
• Other study ID #: LSBCIGO-1-DH3-2016-12
• Status: Enrolling by invitation
• Start date: June 19, 2017
• Est. completion date: June 2022

Study information

• Verified date: January 2019
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: June 2022
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
China	Cancer hospital of Anshan City	Anshan	Liaoning
China	The second hospital of Chaoyang City	Chaoyang	Liaoning
China	Dalian obstetrics and gynaecology hospital	Dalian	Liaoning
China	The first affiliated hospital of Jinzhou Medical University	Jinzhou	Liaoning
China	Shenyang women's and children's hospital	Shenyang	Lioaning
China	The first hospital of China Medical University	Shenyang	Liaoning
China	Women's and children's hospital of Yingkou City	Yingkou	Liaoning

Sponsors (11)

Lead Sponsor

Collaborator

Min Wang

Cancer hospital of Anshan City, Dalian Medical University, Dandong women's and children's hostipal, First Hospital of China Medical University, Hangzhou Dalton Biosciences,LtD, Shenyang women's and children's hostipal, The First People's Hospital of Jingzhou, The Second Affiliated Hospital of Dalian Medical University, The second hospital of Chaoyang City, Women's and children's hospital of Yingkou City

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Review. — View 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). pii: E750. doi: 10.3390/ijms17050750. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	virus load	virus load of 14 types HR-HPV	1 day