Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341146
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2006-06-19
Brief Title:
Molecular Genetics Study of Nasopharyngeal Carcinoma Characterization of NCP Susceptibility Genes
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Molecular Genetics Study of Nasopharyngeal Carcinoma Characterization of NPC Susceptibility Genes
Status:
COMPLETED
Status Verified Date:
2020-06
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:
The objective of this study is to characterize genes associated either with susceptibility or resistance to the development nasopharyngeal carcinoma NPC in a Chinese population where the incidence of NPC is as high as 50 in 100000 NPC has been and remains a unique model of human malignancy for understanding a multi-step carcinogenic process involving a ubiquitous virus Epstein-Barr virus environmental carcinogens and an NPC susceptibility gene Up to 95 of all NPC patients at early or late stage of the disease have IgA antibodies directed to the EBV virus VCA viral capsid antigen Environmental factors have also been implicated as significant risk factors in the development of NPC In addition certain alleles in HLA genes have shown associations with NPC perhaps in concert with a family of T-cell receptor genes TCR Other data suggest that a microsatellite marker on Chromosome 6 may be associated with an NPC-disease associated gene
Detailed Description:
The objective of this study is to characterize genes associated either with susceptibility or resistance to the development nasopharyngeal carcinoma NPC in a Chinese population where the incidence of NPC is as high as 50 in 100000 NPC has been and remains a unique model of human malignancy for understanding a multi-step carcinogenic process involving a ubiquitous virus Epstein-Barr virus environmental carcinogens and an NPC susceptibility gene Up to 95 of all NPC patients at early or late stage of the disease have IgA antibodies directed to the EBV virus VCA viral capsid antigen Environmental factors have also been implicated as significant risk factors in the development of NPC In addition certain alleles in HLA genes have shown associations with NPC perhaps in concert with a family of T-cell receptor genes TCR Other data suggest that a microsatellite marker on Chromosome 6 may be associated with an NPC-disease associated gene
We will use a triad approach to attempt to dissociate genetic from environmental and viral associations of NPC incidence Blood samples will be collected from volunteers probands and family members spouse and child andor parent of patient at two sites in Guangxi Province China the Cancer Research and Control Institute in Wuzhou City and the Cang Wu County Cancer Hospital located about 20 miles from Wuzhou All cases will be EBVIgAVCA positive These triad of samples will provide both control and haplotypic information on cases and controls A database of pertinent clinical and family information will be created from a questionnaire filled in by hospital staff interviewers Blood will be separated into plasma and peripheral blood mononuclear cells PBMCs Plasma will be tested at the Wuzhou Center for EBVIgAVCA The PBMCs will be viably frozen and transported to the LGD at NCIFCRDC where they will be transformed into lymphoblastoid cell lines for extraction of DNA At the LGD the DNAs will be screened for informative polymorphisms in candidate genes by DNA genotyping methods Association analyses will be performed to detect linkages between informative polymorphisms in candidate genes by DNA genotyping methods Association analyses will be performed to detect linkages between informative polymorphisms and clinical and family data If a marker associated with development of NC is found there are potential applications in diagnostics and therapy Further identification of allelic polymorphisms in genes with a role in NPC progression would offer definitive ties of such genes to the carcinogenic process
Following this study the samples will be maintained in our repository and curated through our central Laboratory database Loss or destruction of these samples wil be recorded in our database and cannot impact the study participants in any way We understand that studies subsequent to the completion of this protocol will require additional OHSRIRB approval prior to commencement
We will use a triad approach to attempt to dissociate genetic from environmental and viral associations of NPC incidence Blood samples will be collected from volunteers probands and family members spouse and child andor parent of patient at two sites in Guangxi Province China the Cancer Research and Control Institute in Wuzhou City and the Cang Wu County Cancer Hospital located about 20 miles from Wuzhou All cases will be EBVIgAVCA positive These triad of samples will provide both control and haplotypic information on cases and controls A database of pertinent clinical and family information will be created from a questionnaire filled in by hospital staff interviewers Blood will be separated into plasma and peripheral blood mononuclear cells PBMCs Plasma will be tested at the Wuzhou Center for EBVIgAVCA The PBMCs will be viably frozen and transported to the LGD at NCIFCRDC where they will be transformed into lymphoblastoid cell lines for extraction of DNA At the LGD the DNAs will be screened for informative polymorphisms in candidate genes by DNA genotyping methods Association analyses will be performed to detect linkages between informative polymorphisms in candidate genes by DNA genotyping methods Association analyses will be performed to detect linkages between informative polymorphisms and clinical and family data If a marker associated with development of NC is found there are potential applications in diagnostics and therapy Further identification of allelic polymorphisms in genes with a role in NPC progression would offer definitive ties of such genes to the carcinogenic process
Following this study the samples will be maintained in our repository and curated through our central Laboratory database Loss or destruction of these samples wil be recorded in our database and cannot impact the study participants in any way We understand that studies subsequent to the completion of this protocol will require additional OHSRIRB approval prior to commencement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 02-C-N056 | None | None | None |