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Nasopharyngeal Carcinoma Screening in Zhongshan City

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ClinicalTrials.gov Identifier: NCT02501993
Recruitment Status : Recruiting
First Posted : July 17, 2015
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Mingfang Ji, Zhongshan People's Hospital, Guangdong, China

Brief Summary:

The primary objective is to determine the early diagnosis rate and mortality rate of the Nasopharyngeal Carcinoma (NPC) in the study population.

The secondary objective is to determine the incidence of NPC in the study population.


Condition or disease
Nasopharyngeal Carcinoma

Detailed Description:

The research is to evaluate the effect of NPC screening, also as an extended study of Screening for Nasopharyngeal Carcinoma in High Risk Populations (NCT00941538).

The program was conducted in Xiaolan and Minzhong towns of Zhongshan city in 2012.

All participants will be tested for anti-EBV antibody by using serum samples. Participants are stratified into those having high, moderate and low antibody levels, those having moderate antibody levels are invited to retest annually in the following 3 years and those found to have high antibody levels on these occasions are referred to centers for diagnostic workup for NPC.


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Study Type : Observational
Estimated Enrollment : 25000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serology Screening Test for the Detection of Nasopharyngeal Carcinoma in Zhongshan City
Study Start Date : March 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Screening cohort
All participants will be tested for anti-EBV antibody by using serum samples. Participants are stratified into those having high, moderate and low antibody levels, those having moderate antibody levels are invited to retest annually in the following 3 years and those found to have high antibody levels on these occasions are referred to centers for diagnostic workup for NPC.



Primary Outcome Measures :
  1. The early detection rate (stage I and II) of Nasopharyngeal Carcinoma [ Time Frame: 10 years ]
  2. The mortality rate of Nasopharyngeal Carcinoma [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. The incidence of Nasopharyngeal Carcinoma [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA
Serum and tissue samples


Information from the National Library of Medicine

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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
Residents of Zhongshan City
Criteria

Inclusion Criteria:

  • Subject residents in Zhongshan city
  • Subject is 30 to 59 years of age inclusive
  • 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
  • Subject who is not residing in Zhongshan City

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): NCT02501993


Contacts
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Contact: Mingfang Ji, M.D./Ph.D. jmftbh@sina.com

Locations
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China, Guangdong
Zhongshan People's Hospital Recruiting
Zhongshan, Guangdong, China, 528403
Contact: Mingfang Ji, M.D./Ph.D.       jmftbh@sina.com   
Principal Investigator: Mingfang Ji, M.D./Ph.D.         
Sponsors and Collaborators
Zhongshan People's Hospital, Guangdong, China
Investigators
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Principal Investigator: Mingfang Ji, M.D./Ph.D. Zhongshan People's Hospital, Guangdong, China

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Responsible Party: Mingfang Ji, M.D., Zhongshan People's Hospital, Guangdong, China
ClinicalTrials.gov Identifier: NCT02501993     History of Changes
Other Study ID Numbers: NPC-PRO-002
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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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
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases