Nasopharyngeal Cancinoma (NPC)NCT02586532
Evaluation of the Sensitivity of Endoscopy to Detect Nasopharyngeal Carcinoma (NPC) in an Epstein-Barr Virus (EBV)-Based NPC Screening Project in China
An observational study of Nasopharyngeal Cancinoma (NPC), run by National Cancer Institute (NCI) at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 30 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC)
- How many people
- 828 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2015to 5 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Residents of towns participating in China Demonstration Project.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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.
...
Read the 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.
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Keywords
- Detection, Cancer, Antibody, Biopsy, Registry
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Residents of towns participating in China Demonstration Project. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of Endoscopy and MRI screening for NPC
NPC
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study start19 Oct 2015
- Primary completion5 Jun 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 828 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Allan Hildesheim, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586532
- Sponsor's protocol ID
- 999916007
- Other IDs
- 16-C-N007
- Status last verified
- Dec 2020
- First submitted
- 23 Oct 2015
- Last updated
- 11 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02586532
- Acronym / sponsor ID
- 999916007
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Keywords
- Detection, Cancer, Antibody, Biopsy, Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 828 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 19 Oct 2015 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 26 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Residents of towns participating in China Demonstration Project. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Residents of towns participating in China Demonstration Project.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concordance of Endoscopy and MRI screening for NPC
Time frame: ongoing
NPC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
Related trials for Nasopharyngeal Cancinoma (NPC)
Not yet recruitingPhase 2
Risk-Adapted Anlotinib and PD-L1 for Locoregionally Advanced Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC)
Not yet recruitingPhase 2
Dynamic Plasma EBV DNA-Guided Risk-Adapted Treatment With Becotatug Vedotin (MRG003) Plus PD-1 Blockade in Locoregionally Advanced Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC), Nasopharyngeal Cancer
RecruitingPhase 3
Prophylactic Nanocrystalline Megestrol Acetate Versus Placebo for Chemoradiotherapy-Related Anorexia in Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC)
RecruitingPhase 1
Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) for the Treatment of Recurrent or Metastatic Head and Neck Tumors
Head & Neck Cancer, Nasopharyngeal Cancinoma (NPC)
Not yet recruitingPhase 2
Platinum-Free Regimen in Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Hildesheim, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Cancinoma (NPC), run by National Cancer Institute (NCI) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of Endoscopy and MRI screening for NPC (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.