Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-29 @ 9:39 AM
Study NCT ID:
NCT02586532
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2015-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Sensitivity of Endoscopy to Detect Nasopharyngeal Carcinoma (NPC) in an Epstein-Barr Virus (EBV)-Based NPC Screening Project in China
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
...
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 16-C-N007 | None | None | View |