HR-HPV Multi-site Opportunistic Screening in Liaoning, China
NCT ID: NCT03178136
Last Updated: 2019-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
10000 participants
OBSERVATIONAL
2017-06-19
2022-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Evaluation of Detection of High Risk HPV in Urine
NCT05210348
Early Warning Model of Susceptibility and High-risk Population of Cervical Cancer Related to HPV
NCT04974424
Detection of Minimal Residual Disease Based on HPV ctDNA in Cervical Cancer
NCT05531981
Construction and Validation of a Diagnostic Model for Predicting Molecular Residual Disease and Recurrence of Cervical Cancer Based on Circulating Tumor HPV
NCT06456112
Primary Cervical Cancer Screening by Self-sampling HPV Test
NCT05613283
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
case group
There is no intervention in case group.
No interventions assigned to this group
control group
The control group as the contrast for case group.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
25 Years
65 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
First Hospital of China Medical University
OTHER
Shenyang women's and children's hostipal
UNKNOWN
Dalian Medical University
OTHER
The Second Affiliated Hospital of Dalian Medical University
OTHER
Dandong women's and children's hostipal
UNKNOWN
The First People's Hospital of Jingzhou
OTHER
The second hospital of Chaoyang City
UNKNOWN
Women's and children's hospital of Yingkou City
UNKNOWN
Cancer hospital of Anshan City
UNKNOWN
Hangzhou Dalton Biosciences,LtD
UNKNOWN
Min Wang
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Min Wang
professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Min Wang
Role: STUDY_DIRECTOR
Shengjing Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
The first hospital of China Medical University
Shenyang, Liaoning, China
Women's and children's hospital of Yingkou City
Yingkou, Liaoning, China
Shenyang women's and children's hospital
Shenyang, Lioaning, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LSBCIGO-1-DH3-2016-12
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.