Nasopharyngeal Carcinoma Screening in Zhongshan City

July 12, 2023 updated by: Mingfang Ji, Zhongshan People's Hospital, Guangdong, China

Serology Screening Test for the Detection of Nasopharyngeal Carcinoma in Zhongshan City

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.

Study Overview

Status

Active, not recruiting

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.

Study Type

Observational

Enrollment (Estimated)

25000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Guangdong
      • Zhongshan, Guangdong, China, 528403
        • Zhongshan People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Residents of Zhongshan City

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The early detection rate (stage I and II) of Nasopharyngeal Carcinoma
Time Frame: 10 years
10 years
The mortality rate of Nasopharyngeal Carcinoma
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The incidence of Nasopharyngeal Carcinoma
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mingfang Ji, MD, Zhongshan People's Hospital, Guangdong, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

December 1, 2019

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

July 13, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimated)

July 17, 2015

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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