Nasopharyngeal Carcinoma Screening in Zhongshan City

Sponsor

Zhongshan People's Hospital, Guangdong, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT02501993

Collaborator

(none)

25,000

Enrollment

Location

141

Duration (Months)

177.3

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Mar 1, 2012

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

The early detection rate (stage I and II) of Nasopharyngeal Carcinoma [10 years]
The mortality rate of Nasopharyngeal Carcinoma [10 years]

Secondary Outcome Measures

The incidence of Nasopharyngeal Carcinoma [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan People's Hospital	Zhongshan	Guangdong	China	528403

Sponsors and Collaborators

Zhongshan People's Hospital, Guangdong, China

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT02501993

Other Study ID Numbers:

NPC-PRO-002

First Posted:

Jul 17, 2015

Last Update Posted:

May 5, 2022

Last Verified:

Apr 1, 2022

Additional relevant MeSH terms:

Carcinoma

Nasopharyngeal Carcinoma

Study Results

No Results Posted as of May 5, 2022