Evaluation of the Sensitivity of Endoscopy to Detect Nasopharyngeal Carcinoma (NPC) in an Epstein-Barr Virus (EBV)-Based NPC Screening Project in China

Evaluation of the Sensitivity of Endoscopy to Detect Nasopharyngeal Carcinoma (NPC) in an Epstein-Barrr Virus (EBV)-Based NPC Screening Project in China

Background:

Epstein-Barr virus (EBV) can cause the cancer nasopharyngeal carcinoma (NPC). Early detection of NPC through screening can lead to better treatment outcomes than when it is found later. Currently, NPC is found through visual inspection with an endoscope. It is not clear how well this method works, especially for the identification of small, early cancers. Researchers want to see how well nasal endoscopy works to detect NPC compared to another method called magnetic resonance imaging (MRI).

Objectives:

To evaluate the sensitivity of endoscopy to detect prevalent NPC among people who screen positive for EBV antibodies.

Eligibility:

Participants of the NPC Early Detection Screening Program in China who:

Have increased levels of EBV antibodies

Are otherwise in good health and able to have an MRI procedure

Design:

Participants will be screened with a blood test.

Participants will have a nasal endoscopy.

Participants will have an MRI of the head and neck:

Participants will have lesions identified by either the endoscopy or MRI biopsied and sent to a pathologist for review and diagnosis of NPC.

Researchers will compare NPC detection rates by endoscopy and by MRI to see which method is better able to identify prevalent NPC.

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Study Overview

• Status: Completed
• Conditions: Nasopharyngeal Cancinoma (NPC)

Detailed Description

Epstein-Barr virus (EBV) is a necessary cause of nasopharyngeal carcinoma (NPC). Individuals who develop NPC have been shown to have an altered EBV antibody profile. Ongoing efforts to evaluate EBV antibody testing as a screening test for the early detection of NPC have been launched in China and Taiwan but it is unclear whether the current method to detect NPC among screen-positive individuals (i.e., visual inspection with the aide of an endoscope) is sufficiently sensitive to detect prevalent cancers among screen positive individuals. In the present study, we aim to evaluate the sensitivity of endoscopy to detect NPC. The study is embedded within a large, community-based trial in China to evaluate EBV antibody testing as a screening test that triages individuals into endoscopy for the early detection of NPC. We plan to enroll 1,000 individuals with elevated EBV antibody scores within the active screening arm of the trial in China. Participants will have both endoscopy and MRI performed to detect nasopharyngeal lesions. Lesions identified by either method will be biopsied and evaluated for the presence of NPC. NPC cases will also be identified by linkage to the regional cancer registry. We expect to identify a total of 25 histologically confirmed NPC cases through endoscopy, MRI and/or registry linkage. The sensitivity of endoscopy to detect prevalent NPC will be estimated. Characteristics of prevalent NPC cases detected by MRI or registry linkage but missed by endoscopy will be described, with respect to clinical stage, socio-demographic and other characteristics. This study is an important complement to the ongoing screening trial in China, as a highly sensitive EBV-based screening test can ultimately be successful only if methods available to identify cancer among screen-positive individuals are equally sensitive. Demonstration of high sensitivity of endoscopy to detect NPC will be reassuring. Demonstration of reduced sensitivity will trigger the need to consider alternatives to endoscopy for the diagnosis of NPC.

• Study Type: Observational
• Enrollment (Actual): 828

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Sun Yat-sen University Cancer Center (SYSUCC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 59 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Residents of towns participating in China Demonstration Project.

Description

• INCLUSION CRITERIA:

Already participating in the NPC Early Detection Screening Program;

Increased levels of EBV antibodies and referred for nasal endoscopy;

No metallic materials in the body;

Have a health examination score of 0 or 1;

Normal creatinine blood levels; and

For women, not pregnant.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Residents of towns participating in China Demonstration Project.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance of Endoscopy and MRI screening for NPC	NPC	ongoing

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 19, 2015
• Primary Completion (ACTUAL): June 5, 2020
• Study Completion (ACTUAL): June 5, 2020

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (ESTIMATE): October 26, 2015

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Detection; Cancer; Biopsy; Antibody; Registry
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma
• Other Study ID Numbers: 999916007; 16-C-N007