Ignite Creation Date:
2024-05-06 @ 10:08 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03178136
Status:
UNKNOWN
Last Update Posted:
2019-01-03
First Post:
2017-05-20
Brief Title:
HR-HPV Multi-site Opportunistic Screening in Liaoning China
Sponsor:
Min Wang
Organization:
Shengjing Hospital
Study Overview
Official Title:
HR-HPV Multi-site Opportunistic Screening in Liaoning China
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is universally accepted that the persistent infection of high-risk human papillomavirusHR-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 technologysequentially 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 papillomavirusHR-HPV is the definite causeespecially the infection of human papillomavirus 16human papillomavirus 18HPV16HPV18 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 2CIN2 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 3DH3 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 Chinapatients accord with inclusion criteriaN10000 sign informed consent and fill out a information form Gynecologist collect cervical cell with sampling instrument Detecting the virus load of HPV16HPV18 and other 12 types HR-HPV the positive result is cut-off 10pgml HPV16HPV18 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
A detect reagent named Dalton hybrid 3DH3 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 Chinapatients accord with inclusion criteriaN10000 sign informed consent and fill out a information form Gynecologist collect cervical cell with sampling instrument Detecting the virus load of HPV16HPV18 and other 12 types HR-HPV the positive result is cut-off 10pgml HPV16HPV18 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None