- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02586532
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.
...
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Guangzhou, China
- Sun Yat-sen University Cancer Center (SYSUCC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Residents of towns participating in China Demonstration Project.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concordance of Endoscopy and MRI screening for NPC
Time Frame: ongoing
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NPC
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ongoing
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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