- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00341146
Molecular Genetics Study of Nasopharyngeal Carcinoma: Characterization of NCP Susceptibility Gene(s)
Molecular Genetics Study of Nasopharyngeal Carcinoma: Characterization of NPC Susceptibility Gene(s)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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 100,000. 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 and/or 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 EBV/IgA/VCA 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 EBV/IgA/VCA. The PBMCs will be viably frozen and transported to the LGD at NCI/FCRDC, 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 OHSR/IRB approval prior to commencement.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Beijing, Kina
- Institute for Viral Disease Control & Prevention
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
- INCLUSION CRITERIA:
Individuals must meet the following eligibility criteria to be entered into the NPC study.
Cohort A: Proband: NPC positive (stage III or IV), age less than 50 at time of NPC diagnosis, and EBV/IgA/VCA positive. Spouse of Proband. Child of proband and of spouse (or a parent of the proband)
Cohort B: EBV/IgA/VCA positive 12 years ago and NPC negative. Spouse of proband. Child of proband and of spouse (or a parent of the proband).
EXCLUSION CRITERIA:
Persons with any of the following will be excluded from the study.
Persons who are unwilling or unable to given informed consent, or whose spouse and child(ren) (or parent) are willing to participate and give informed consent/assent.
Persons with no living spouse of child(ren)/parent.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Collection from 9100 participants
Tidsramme: 2006
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DNA Genotyping
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2006
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Daniel W McVicar, Ph.D., National Cancer Institute (NCI)
Publikationer og nyttige links
Generelle publikationer
- O'Brien SJ, Nelson GW, Winkler CA, Smith MW. Polygenic and multifactorial disease gene association in man: Lessons from AIDS. Annu Rev Genet. 2000;34:563-591. doi: 10.1146/annurev.genet.34.1.563.
- Zeng Y. Seroepidemiological studies on nasopharyngeal carcinoma in China. Adv Cancer Res. 1985;44:121-38. doi: 10.1016/s0065-230x(08)60027-5. No abstract available.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Pharyngeale neoplasmer
- Otorhinolaryngologiske neoplasmer
- Neoplasmer i hoved og hals
- Nasopharyngeale sygdomme
- Pharyngeale sygdomme
- Stomatognatiske sygdomme
- Otorhinolaryngologiske sygdomme
- Nasopharyngeale neoplasmer
- Karcinom
- Nasopharyngealt karcinom
Andre undersøgelses-id-numre
- 999902056
- 02-C-N056
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Kliniske forsøg med Nasopharyngealt karcinom
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National Cancer Institute (NCI)AfsluttetNivolumab til behandling af patienter med tilbagevendende og/eller metastatisk nasopharyngeal cancerTilbagevendende nasopharynx carcinom | Stadie III Nasopharyngeal Carcinoma AJCC v7 | Stadie IV Nasopharyngeal Carcinoma AJCC v7 | Stadie IVA Nasopharyngeal Carcinoma AJCC v7 | Stadie IVB Nasopharyngeal Carcinoma AJCC v7 | Stadie IVC Nasopharyngeal Carcinoma AJCC v7 | Nasopharyngeal ikke-eratiniserende...Forenede Stater, Singapore, Kina
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National Cancer Institute (NCI)NRG OncologyAfsluttetTilbagevendende nasopharyngeal karcinom | Stadie IV Nasopharyngeal Carcinoma AJCC v8 | Metastatisk nasopharyngeal karcinom | Metastatisk nasopharyngeal keratiniserende planocellulær karcinom | Metastatisk nasopharyngealt ikke-eratiniserende karcinom | Metastatisk nasopharyngeal udifferentieret... og andre forholdForenede Stater, Canada, Kina, Singapore
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Alliance for Clinical Trials in OncologyIkke rekrutterer endnuTilbagevendende nasopharyngeal karcinom | Stadie IV Nasopharyngeal Carcinoma AJCC v8 | Metastatisk nasopharyngeal karcinom
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National Cancer Institute (NCI)RekrutteringTilbagevendende nasopharyngeal karcinom | Stadie IV Nasopharyngeal Carcinoma AJCC v8 | Metastatisk nasopharyngeal karcinomForenede Stater, Hong Kong
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeTilbagevendende peritoneal malignt mesotheliom | Tilbagevendende Malignt lungehindekræft | Vaginalt planocellulært karcinom, ikke andet specificeret | Neuroendokrint karcinom | Pancreas neuroendokrin tumor | Tilbagevendende Merkelcellekarcinom | Tilbagevendende nasopharynx carcinom | Tillæg Adenocarcinom og andre forholdForenede Stater
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Fourth Affiliated Hospital of Guangxi Medical UniversityGuilin Medical University, China; Wuzhou Red Cross Hospital; Second Affiliated... og andre samarbejdspartnereRekrutteringNasopharyngeal Carcinoma af AJCC V8 StageKina
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National Cancer Institute (NCI)Aktiv, ikke rekrutterendeMetastatisk blæreurothelial karcinom | Metastatisk Ureter Urothelial Carcinoma | Stadie IV Blære Urothelial Carcinoma AJCC v7 | Metastatisk nyrebækken og Ureter Urothelial CarcinomaForenede Stater
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Fujian Cancer HospitalIkke rekrutterer endnuNasopharyngeal Carcinoma af AJCC V8 Stage
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Chongqing University Cancer HospitalRekrutteringNasopharyngeal Carcinoma af AJCC V8 StageKina