Nasopharyngeal NeoplasmsNCT00393224
Defining the Clinical Utility of EBV Antibody Screening to Identify Individuals Susceptible to Nasopharyngeal Carcinoma (NPC) Within High-Risk, Multiplex NPC Families
An observational study of Nasopharyngeal Neoplasms, run by National Cancer Institute (NCI) at 1 site in China.
Trial summary
In an effort to identify genetic factors linked to the development of nasopharyngeal cancer (NPC), the researchers identified and sampled 2,394 individuals from Taiwanese families in which two or more relatives had been diagnosed with NPC. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Nasopharyngeal Neoplasms
- How many people
- 952 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2005to 2 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a hospital based family cohort
Who may be able to join
- The 2,394 unaffected family members who previously participated in the family study of nasopharyngeal carcinoma (NPC) in Taiwan between 1996 and 2004.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Defining Markers of Susceptibility to Nasopharyngeal Carcinoma (NPC) Within High-Risk, Multiplex NPC Families
In an effort to identify genetic factors linked to the development of nasopharyngeal cancer (NPC), the researchers identified and sampled 2,394 individuals from Taiwanese families in which two or more relatives had been diagnosed with NPC. Serum from these individuals was tested for three anti-Epstein-Barr virus (EPV) antibodies associated with elevated risk of NPC. Results indicate that apparently healthy individuals from high-risk families have a nearly threefold elevation in their EBV antibody prevalence compared with the general population. However, the clinical implications of this finding are not yet understood.
To clarify the implications, the 2,394 unaffected individuals from the multiplex family study will be invited to participate in the current study. Approximately 1,600 individuals are expected to participate.
Read more
Participants will have an ear, nose, and throat examination to determine if they have occult or symptomatic NPC. Their levels of EBV antibody at the time of initial recruitment will be correlated with NPC detection in the period between initial recruitment and the present study. Participants will also be asked to complete a brief risk factor questionnaire and to donate blood, saliva, a nasopharyngeal swab, nasopharyngeal tissue, and urine for future studies.
Currently, no accepted clinical management protocol exists for screening unaffected members from families at high risk of NPC development. Results from this study have the potential to significantly impact the clinical management and follow-up of individuals with a family history of NPC.
Read the detailed description
The purpose of this proposed study is to evaluate the clinical utility of serum EBV antibody testing for the identification of individuals at increased risk of nasopharyngeal carcinoma (NPC) within high-risk, NPC multiplex families.
2,394 unaffected individuals from Taiwanese families, in which two or more relatives have been diagnosed with NPC, have been identified and sampled as part of an ongoing collaboration to identify genetic factors linked to NPC development. Serum from these individuals has been tested for three anti-EBV antibodies (VCA IgA, EBNA1 IgA, and anti-DNase) known to be associated with elevated risk of prevalent and incident NPC in general population studies. Results from testing of our study population indicate that apparently healthy individuals from high-risk multiplex families have a near 3-fold elevation in their EBV antibody prevalence when compared to the EBV antibody prevalence observed in the general community for these same EBV markers. However, the clinical implications of this apparent elevation in EBV antibody reactivity are not yet understood.
Therefore, we propose to evaluate whether individuals within our previously conducted high-risk family study with elevations in EBV antibody levels are at increased risk of incident NPC. Individual markers (VCA IgA, EBNIA1 IgA and anti-DNase antibodies) and combinations of markers will be evaluated to determine their performance as screening tests for NPC risk in high-risk multiplex families.
To achieve this goal, we propose to invite the 2,394 unaffected individuals from our multiplex family study, defined as those families with greater than or equal to 2 NPC. As a result of our recruitment efforts, we expect approximately 1,600 subjects to participate in an ear, nose, and throat (ENT) examination by an expert otolaryngologist to determine whether any of these individuals has occult or symptomatic NPC. We will correlate the three EBV antibody screening tests performed at the time of initial recruitment into our family study with NPC detection in the period between initial recruitment into the family study and the present study (median time between original EBV antibody testing and clinical evaluation = 5.5 years; range = less than 1 year - 10 years).
In addition to histopathological specimens collected for NPC diagnosis, participants in this study will be asked to agree to a brief risk factor questionnaire and to donate blood, saliva, a nasopharyngeal swab, nasopharyngeal tissue, and urine for future studies.
No accepted clinical management protocol exists for screening unaffected members from families at high-risk of NPC development. Results from this study have the potential to significantly impact the clinical management and follow-up of individuals with a family history of NPC.
- Conditions
- Nasopharyngeal Neoplasms
- Keywords
- Epidemiology, Nasopharyngeal Carcinoma, Genetic, Viruses, Cancer, NPC
- Medical subject headings
- Nasopharyngeal Neoplasms, Nasopharyngeal Carcinoma, Virus Diseases, 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 |
|---|---|---|
| cohort | hospital based family cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 posted27 Oct 2006 (estimated)
- Study start5 Jul 2005
- Primary completion2 Jun 2020
- Study completion2 Jun 2020
Why it stopped: Determined not to be human subject reseach
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal NeoplasmsStudies 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
- Other
- Enrolment
- 952 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
- NCT00393224
- Sponsor's protocol ID
- 999905187
- Other IDs
- 05-C-N187
- Status last verified
- Jun 2020
- First submitted
- 26 Oct 2006
- Last updated
- 4 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cohen JI. Epstein-Barr virus infection. N Engl J Med. 2000 Aug 17;343(7):481-92. doi: 10.1056/NEJM200008173430707. No abstract available.
PubMed 10944566Hsu JL, Glaser SL. Epstein-barr virus-associated malignancies: epidemiologic patterns and etiologic implications. Crit Rev Oncol Hematol. 2000 Apr;34(1):27-53. doi: 10.1016/s1040-8428(00)00046-9.
PubMed 10781747Zeng Y, Zhang LG, Wu YC, Huang YS, Huang NQ, Li JY, Wang YB, Jiang MK, Fang Z, Meng NN. Prospective studies on nasopharyngeal carcinoma in Epstein-Barr virus IgA/VCA antibody-positive persons in Wuzhou City, China. Int J Cancer. 1985 Nov 15;36(5):545-7. doi: 10.1002/ijc.2910360505.
PubMed 4055129
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Markers of Susceptibility to Nasopharyngeal Carcinoma (NPC) Within High-Risk, Multiplex NPC Families
- ClinicalTrials.gov ID
- NCT00393224
- Acronym / sponsor ID
- 999905187
- Conditions
- Nasopharyngeal Neoplasms
- Keywords
- Epidemiology, Nasopharyngeal Carcinoma, Genetic, Viruses, Cancer, NPC
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Determined not to be human subject reseach
- Enrolment
- 952 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 5 Jul 2005 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 27 Oct 2006 (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.
In an effort to identify genetic factors linked to the development of nasopharyngeal cancer (NPC), the researchers identified and sampled 2,394 individuals from Taiwanese families in which two or more relatives had been diagnosed with NPC. Serum from these individuals was tested for three anti-Epstein-Barr virus (EPV) antibodies associated with elevated risk of NPC. Results indicate that apparently healthy individuals from high-risk families have a nearly threefold elevation in their EBV antibody prevalence compared with the general population. However, the clinical implications of this finding are not yet understood.
To clarify the implications, the 2,394 unaffected individuals from the multiplex family study will be invited to participate in the current study. Approximately 1,600 individuals are expected to participate.
Participants will have an ear, nose, and throat examination to determine if they have occult or symptomatic NPC. Their levels of EBV antibody at the time of initial recruitment will be correlated with NPC detection in the period between initial recruitment and the present study. Participants will also be asked to complete a brief risk factor questionnaire and to donate blood, saliva, a nasopharyngeal swab, nasopharyngeal tissue, and urine for future studies.
Currently, no accepted clinical management protocol exists for screening unaffected members from families at high risk of NPC development. Results from this study have the potential to significantly impact the clinical management and follow-up of individuals with a family history of NPC.
Detailed description
The purpose of this proposed study is to evaluate the clinical utility of serum EBV antibody testing for the identification of individuals at increased risk of nasopharyngeal carcinoma (NPC) within high-risk, NPC multiplex families.
2,394 unaffected individuals from Taiwanese families, in which two or more relatives have been diagnosed with NPC, have been identified and sampled as part of an ongoing collaboration to identify genetic factors linked to NPC development. Serum from these individuals has been tested for three anti-EBV antibodies (VCA IgA, EBNA1 IgA, and anti-DNase) known to be associated with elevated risk of prevalent and incident NPC in general population studies. Results from testing of our study population indicate that apparently healthy individuals from high-risk multiplex families have a near 3-fold elevation in their EBV antibody prevalence when compared to the EBV antibody prevalence observed in the general community for these same EBV markers. However, the clinical implications of this apparent elevation in EBV antibody reactivity are not yet understood.
Therefore, we propose to evaluate whether individuals within our previously conducted high-risk family study with elevations in EBV antibody levels are at increased risk of incident NPC. Individual markers (VCA IgA, EBNIA1 IgA and anti-DNase antibodies) and combinations of markers will be evaluated to determine their performance as screening tests for NPC risk in high-risk multiplex families.
To achieve this goal, we propose to invite the 2,394 unaffected individuals from our multiplex family study, defined as those families with greater than or equal to 2 NPC. As a result of our recruitment efforts, we expect approximately 1,600 subjects to participate in an ear, nose, and throat (ENT) examination by an expert otolaryngologist to determine whether any of these individuals has occult or symptomatic NPC. We will correlate the three EBV antibody screening tests performed at the time of initial recruitment into our family study with NPC detection in the period between initial recruitment into the family study and the present study (median time between original EBV antibody testing and clinical evaluation = 5.5 years; range = less than 1 year - 10 years).
In addition to histopathological specimens collected for NPC diagnosis, participants in this study will be asked to agree to a brief risk factor questionnaire and to donate blood, saliva, a nasopharyngeal swab, nasopharyngeal tissue, and urine for future studies.
No accepted clinical management protocol exists for screening unaffected members from families at high-risk of NPC development. Results from this study have the potential to significantly impact the clinical management and follow-up of individuals with a family history of NPC.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort | – | –hospital based family cohort |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a hospital based family cohort
Key inclusion criteria (1 listed)
- The 2,394 unaffected family members who previously participated in the family study of nasopharyngeal carcinoma (NPC) in Taiwan between 1996 and 2004.
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
NPC
Time frame: ongoing
NPC
Results and safety
The study was stopped early (reason given: Determined not to be human subject reseach). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Background: PubMed 10944566Cohen JI. Epstein-Barr virus infection. N Engl J Med. 2000 Aug 17;343(7):481-92. doi: 10.1056/NEJM200008173430707. No abstract available.
- Background: PubMed 10781747Hsu JL, Glaser SL. Epstein-barr virus-associated malignancies: epidemiologic patterns and etiologic implications. Crit Rev Oncol Hematol. 2000 Apr;34(1):27-53. doi: 10.1016/s1040-8428(00)00046-9.
- Background: PubMed 4055129Zeng Y, Zhang LG, Wu YC, Huang YS, Huang NQ, Li JY, Wang YB, Jiang MK, Fang Z, Meng NN. Prospective studies on nasopharyngeal carcinoma in Epstein-Barr virus IgA/VCA antibody-positive persons in Wuzhou City, China. Int J Cancer. 1985 Nov 15;36(5):545-7. doi: 10.1002/ijc.2910360505.
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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 Neoplasms, 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 1 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: stopped early, as of the sponsor's last update on 4 Jun 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 was stopped early (reason given: Determined not to be human subject reseach). Results are not available in the source record.
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?
NPC (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00393224, which also lists 3 linked publications.
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 4 Jun 2020.