Nasopharyngeal Carcinoma Screening in Zhongshan City | NCT02501993

Studies
Nasopharyngeal Carcinoma Screening in Zhongshan City

NCT02501993

Sponsor

Zhongshan People's Hospital, Guangdong, China

Status

Unknown status

Last Update Posted

Jul 13, 2023Actual

Enrollment

25,000Estimated

Phase

Not provided

Conditions

Nasopharyngeal Carcinoma

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Dec 2019Actual

Completion Date

Dec 2023Estimated

First Submitted Date

Jul 13, 2015

First Submission Date that Met QC Criteria

Jul 15, 2015

First Posted Date

Jul 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2023

Last Update Posted Date

Jul 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Zhongshan People's Hospital, Guangdong, ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
The incidence of Nasopharyngeal Carcinoma		10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

59 Years

Standard Ages

Adult

Study Population

Residents of Zhongshan City

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mingfang Ji, MD	Zhongshan People's Hospital, Guangdong, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan People's Hospital		Zhongshan	Guangdong	528403	China

Condition Browse Module

MeSH Terms

ID	Term
D000077274	Nasopharyngeal Carcinoma

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

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