Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2026-02-27 @ 8:26 AM
Study NCT ID:
NCT04085900
Status:
RECRUITING
Last Update Posted:
2023-07-13
First Post:
2019-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City
Sponsor:
Zhongshan People's Hospital, Guangdong, China
Organization:
Study Overview
Official Title:
Searching for Early Detection Biomarkers of Nasopharyngeal Carcinoma in Zhongshan City
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
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:
All participants will be tested for EBV associated biomarkers, including EBNA1-IgA, VCA-IgA, BNLF2b total antibodies (P85-Ab) et al. For all male participants and P85-Ab positive female participants, EBV DNA in plasma will be tested. Screening positive participants will be followed up annually.
All subjects will also be followed by record linkage to Cancer Register and Population Register.
All subjects will also be followed by record linkage to Cancer Register and Population Register.
Detailed Description:
Sample selection
\- Select communities of 20,000 to 40,000 populations in Zhongshan City and Wuzhou city as the investigators' fields.
Participants recruitment
* Subjects voluntarily attend this screening study Informed consent - Informed consent forms will be collected at the recruitment. Questionnaires.
* Face-to-face interviews are conducted by well-trained investigators.
Tests and follow up
* At initial screening, all participants will be tested for EBV associated biomarkers, including EBNA1-IgA, VCA-IgA, P85-Ab et al. And in males, EBV-DNA will be tested. Based on EBNA1-IgA, VCA-IgA, participants will be stratified into high, moderate and low risk. Screening positive include P85-Ab positive, high or moderate risk of NPC or EBV DNA positive. The rest will be screening negative.
* During the initial screening and following up, people with high risk or P85-Ab positive will refer to the diagnostic workup for NPC. Briefly, fiberoptic endoscopy and pathological biopsy will be performed by otorhinolaryngologists.
* Screening positive people not diagnosed as nasopharyngeal carcinoma in the first year will be followed up annually.
* EBV DNA single positive people will refer to the diagnostic workup for NPC in the third year of follow up.
* The rest of the blood samples will be stored at the biobank of Zhongshan People's Hospital for further research.
* All subjects will also be followed by record linkage to Cancer Register and Population Register.
\- Select communities of 20,000 to 40,000 populations in Zhongshan City and Wuzhou city as the investigators' fields.
Participants recruitment
* Subjects voluntarily attend this screening study Informed consent - Informed consent forms will be collected at the recruitment. Questionnaires.
* Face-to-face interviews are conducted by well-trained investigators.
Tests and follow up
* At initial screening, all participants will be tested for EBV associated biomarkers, including EBNA1-IgA, VCA-IgA, P85-Ab et al. And in males, EBV-DNA will be tested. Based on EBNA1-IgA, VCA-IgA, participants will be stratified into high, moderate and low risk. Screening positive include P85-Ab positive, high or moderate risk of NPC or EBV DNA positive. The rest will be screening negative.
* During the initial screening and following up, people with high risk or P85-Ab positive will refer to the diagnostic workup for NPC. Briefly, fiberoptic endoscopy and pathological biopsy will be performed by otorhinolaryngologists.
* Screening positive people not diagnosed as nasopharyngeal carcinoma in the first year will be followed up annually.
* EBV DNA single positive people will refer to the diagnostic workup for NPC in the third year of follow up.
* The rest of the blood samples will be stored at the biobank of Zhongshan People's Hospital for further research.
* All subjects will also be followed by record linkage to Cancer Register and Population Register.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: