Nasopharyngeal Carcinoma Screening in Zhongshan City

NCT02501993 | Unknown

• 1 other identifier: NPC-PRO-002
• Study Type: observational
• Target: 25,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (2)

• The early detection rate (stage I and II) of Nasopharyngeal Carcinoma

  10 years

• The mortality rate of Nasopharyngeal Carcinoma

  10 years

Secondary Outcomes (1)

• The incidence of Nasopharyngeal Carcinoma

  10 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Residents of Zhongshan City

You may qualify if:

• 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.

You may not qualify if:

• Subject has heavy cardiovascular, liver or kidney disease
• Subject has medical record of nasopharyngeal carcinoma
• Subject who is not residing in Zhongshan City

Sponsors & Collaborators

• Zhongshan People's Hospital, Guangdong, China: lead

Study Sites (1)

Zhongshan People's Hospital

Zhongshan, Guangdong, 528403, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and tissue samples

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Mingfang Ji, MD

  Zhongshan People's Hospital, Guangdong, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 17, 2015
• Study Start: March 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Locations

CN (1)