Nasopharyngeal CarcinomaNCT00341146
Molecular Genetics Study of Nasopharyngeal Carcinoma: Characterization of NCP Susceptibility Gene(s)
An observational study of Nasopharyngeal Carcinoma, run by National Cancer Institute (NCI) at 1 site in China.
Trial 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 100,000. Read more about this study
- Who is it for?
- Ages 7 to 90 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- How many people
- 6,490 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2001to 20 Sep 2006
- 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 7 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chinese population with a high incidence of NPC
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Genetics Study of Nasopharyngeal Carcinoma: Characterization of NPC Susceptibility Gene(s)
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.
Read the 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 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.
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Cancer, Catonese Chinese, Genetic Predisposition, Genotyping, Triad analysis, Nasopharyngeal Cancer, NPC
- Medical subject headings
- Nasopharyngeal Carcinoma, Neoplasms, Genetic Predisposition to Disease, Nasopharyngeal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection from 9100 participants
DNA Genotyping
Measured: 2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start1 Apr 2001
- Primary completion20 Aug 2006
- Study completion20 Sep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies 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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 6,490 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Daniel W McVicar, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341146
- Sponsor's protocol ID
- 999902056
- Other IDs
- 02-C-N056
- Status last verified
- Jun 2020
- First submitted
- 19 Jun 2006
- Last updated
- 16 Jun 2020
- Results posted
- No
Publications
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.
PubMed 11092839Zeng 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.
PubMed 2994402
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Genetics Study of Nasopharyngeal Carcinoma: Characterization of NPC Susceptibility Gene(s)
- ClinicalTrials.gov ID
- NCT00341146
- Acronym / sponsor ID
- 999902056
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Cancer, Catonese Chinese, Genetic Predisposition, Genotyping, Triad analysis, Nasopharyngeal Cancer, NPC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,490 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Apr 2001 (actual)
- Primary completion
- 20 Aug 2006 (actual)
- Study completion
- 20 Sep 2006 (actual)
- First posted
- 21 Jun 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.
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.
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 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.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese population with a high incidence of NPC
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
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
Collection from 9100 participants
Time frame: 2006
DNA Genotyping
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 16 Jun 2020.
- Background: PubMed 11092839O'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.
- Background: PubMed 2994402Zeng 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.
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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.
Daniel W McVicar, 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 Carcinoma, 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 3 inclusion and 3 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 16 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 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?
Collection from 9100 participants (time frame: 2006). 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 NCT00341146, which also lists 2 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 16 Jun 2020.