Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04085900
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Mingfang Ji, Zhongshan People's Hospital, Guangdong, China

Tracking Information
First Submitted Date September 9, 2019
First Posted Date September 11, 2019
Last Update Posted Date September 11, 2019
Estimated Study Start Date September 2019
Estimated Primary Completion Date September 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 9, 2019)
Sensitivity, specificity, positive predictive value and negative predictive value of different EBV associated biomarkers [ Time Frame: 5 years ]
To evaluated the screening performance of different EBV associated biomarkers for NPC
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 9, 2019)
  • Early diagnosis rate of Nasopharyngeal Carcinoma [ Time Frame: 10 years ]
    To improve early diagnosis rate of Nasopharyngeal Carcinoma
  • Identification of early detection markers of Nasopharyngeal Carcinoma [ Time Frame: 10 years ]
    To identify early expression markers of Nasopharyngeal Carcinoma
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City
Official Title Searching for Early Detection Biomarkers of Nasopharyngeal Carcinoma in Zhongshan City
Brief Summary

All participants will be tested for EBV associated biomarkers, including EBNA1/IgA, VCA/IgA, BNLF2b/IgG et al. And in males, EBV-DNA will be tested.Screening positive people will be followed up annually. And screening negative are invited to retest every four year.

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 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, BNLF2b/IgG 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. High or moderate risk will be defined as screening positive, and screening positive also includes people with BNLF2b/IgG positive or EBV-DNA positive. The rest will be screening negative.
  • Screening positive people will be followed up annually. And screening negative are invited to retest every four year.
  • During the initial screening and following up, people with high risk, or BNLF2b/IgG positive, or EBV-DNA positive, will refer to the diagnostic workup for NPC. Briefly, fiberoptic endoscopy and pathological biopsy will be performed by otorhinolaryngologists.
  • 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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Retention:   Samples With DNA
Description:
Blood and saliva samples
Sampling Method Non-Probability Sample
Study Population Healthy residences in Zhongshan City.
Condition Nasopharyngeal Carcinoma
Intervention Not Provided
Study Groups/Cohorts Screening cohort
All participants will be tested for EBV associated biomarkers, including EBNA1/IgA, VCA/IgA, BNLF2b/IgG et al. And in males, EBV-DNA will be tested.Screening positive people will be followed up annually. And screening negative are invited to retest every four year.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 9, 2019)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2029
Estimated Primary Completion Date September 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subject residents in Zhongshan city
  • Subject has no medical record of nasopharyngeal carcinoma
  • ECOG 0-2
  • Subject has psychical condition and well consciousness
  • Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.

Exclusion Criteria:

  • Subject has heavy cardiovascular, liver or kidney disease
  • Subject has medical record of nasopharyngeal carcinoma
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 59 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Mingfang Ji, MD,PhD 86-760-89880417 jmftbh@sina.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04085900
Other Study ID Numbers NPC-PRO-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mingfang Ji, Zhongshan People's Hospital, Guangdong, China
Study Sponsor Zhongshan People's Hospital, Guangdong, China
Collaborators Not Provided
Investigators
Principal Investigator: Mingfang Ji, MD,PhD Zhongshan People's Hospital, Guangdong, China
PRS Account Zhongshan People's Hospital, Guangdong, China
Verification Date September 2019