Evaluation of the Sensitivity of Endoscopy to Detect Nasopharyngeal Carcinoma (NPC) in an Epstein-Barr Virus (EBV)-Based NPC Screening Project in China
Condition: Nasopharyngeal Cancinoma (NPC)
MeSH terms: Nasopharyngeal Carcinoma
Study type: Observational

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.

      ...
    

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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Residents of towns participating in China Demonstration Project.
      
Keywords: Detection; Cancer; Antibody; Biopsy; Registry