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

Nasopharyngeal Cancinoma (NPC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586532
• Other study ID #: 999916007
• Secondary ID: 16-C-N007
• Status: Completed
• Start date: October 19, 2015
• Est. completion date: June 5, 2020

Study information

• Verified date: December 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

...

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 828
• Est. completion date: June 5, 2020
• Est. primary completion date: June 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 59 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Nasopharyngeal Cancinoma (NPC)
• Nasopharyngeal Carcinoma

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center (SYSUCC)	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance of Endoscopy and MRI screening for NPC	NPC	ongoing