Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393224
Status:
TERMINATED
Last Update Posted:
2020-06-04
First Post:
2006-10-26
Brief Title:
Defining the Clinical Utility of EBV Antibody Screening to Identify Individuals Susceptible to Nasopharyngeal Carcinoma NPC Within High-Risk Multiplex NPC Families
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Defining Markers of Susceptibility to Nasopharyngeal Carcinoma NPC Within High-Risk Multiplex NPC Families
Status:
TERMINATED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Determined not to be human subject reseach
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In an effort to identify genetic factors linked to the development of nasopharyngeal cancer NPC the researchers identified and sampled 2394 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 2394 unaffected individuals from the multiplex family study will be invited to participate in the current study Approximately 1600 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
To clarify the implications the 2394 unaffected individuals from the multiplex family study will be invited to participate in the current study Approximately 1600 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
2394 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 2394 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 1600 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 55 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
2394 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 2394 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 1600 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 55 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-C-N187 | None | None | None |