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Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City

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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

Study Description
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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.


Condition or disease
Nasopharyngeal Carcinoma

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Searching for Early Detection Biomarkers of Nasopharyngeal Carcinoma in Zhongshan City
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2029
Estimated Study Completion Date : December 2029

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Early diagnosis rate of Nasopharyngeal Carcinoma [ Time Frame: 10 years ]
    To improve early diagnosis rate of Nasopharyngeal Carcinoma

  2. Identification of early detection markers of Nasopharyngeal Carcinoma [ Time Frame: 10 years ]
    To identify early expression markers of Nasopharyngeal Carcinoma


Biospecimen Retention:   Samples With DNA
Blood and saliva samples

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy residences in Zhongshan City.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085900


Contacts
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Contact: Mingfang Ji, MD,PhD 86-760-89880417 jmftbh@sina.com

Locations
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China, Guangdong
Zhongshan People's Hospital Recruiting
Zhongshan, Guangdong, China, 528403
Contact: Mingfang Ji, MD, PhD       jmftbh@sina.com   
Principal Investigator: Mingfang Ji, MD, PhD         
Sponsors and Collaborators
Zhongshan People's Hospital, Guangdong, China
Investigators
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Principal Investigator: Mingfang Ji, MD,PhD Zhongshan People's Hospital, Guangdong, China
More Information
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Responsible Party: Mingfang Ji, Dr. Mingfang Ji, Zhongshan People's Hospital, Guangdong, China
ClinicalTrials.gov Identifier: NCT04085900     History of Changes
Other Study ID Numbers: NPC-PRO-003
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Keywords provided by Mingfang Ji, Zhongshan People's Hospital, Guangdong, China:
Screening
Nasopharyngeal Carcinoma
Biomarker
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
 Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases