Nasopharyngeal NeoplasmsNCT00342147
Family Study of Head and Neck Cancers in Taiwan
An observational study of Nasopharyngeal Neoplasms and Herpesvirus 4, Human, run by National Cancer Institute (NCI) at 1 site in China.
Trial summary
Nasopharyngeal carcinoma is a rare tumor among Caucasians which occurs with high incidence among individuals of Chinese descent. The disease is believed to have a multifactorial etiology with genetic, viral, and other environmental factors being involved. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Nasopharyngeal Neoplasms, Herpesvirus 4, Human
- How many people
- 3,795 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 1995to 5 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 high risk population of families for NPC
Who may be able to join
- Subjects with head and neck cancer who are participants in the case-control study of NPC or the parallel studies of head and neck cancers conducted by the Taiwanese.
- Subjects who report one or more first degree family members affected with NPC, oral cancer, or laryngeal cancer.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Nasopharyngeal carcinoma is a rare tumor among Caucasians which occurs with high incidence among individuals of Chinese descent. The disease is believed to have a multifactorial etiology with genetic, viral, and other environmental factors being involved. Little is known, however, about the genetic component of this disease.
We have recently completed subject recruitment for a case-control study of NPC in Taiwan. Using information obtained from the NPC cases recruited into this NCI-sponsored case-control study as well as from a parallel cross-sectional study conducted by our Taiwanese collaborators, we have been able to identify 120-150 families with multiple family members affected with NPC.
Read more
The purpose of the study described herein is to determine the role of inherited genetic factors in the etiology of NPC and to examine the effect of these genetic susceptibility factors on risk associated with environmental exposures.
Families will initially be contacted via the proband who previously participated in our case-control and cross-sectional studies. Subsequently, informative family members will be asked to visit the study clinic to participate in the study. A family history questionnaire will be administered to the proband from each of the families selected for study. In addition, a risk factor questionnaire will be administered to all participating family members, and 30-40 ml of blood and an oral sample will be obtained from each study participant. Additional study components include medical record review to verify the diagnosis of NPC, retrieval of tumor tissue blocks as a source of DNA for study, and clinical exams on a sample of unaffected individuals to exclude the possibility of prevalent, undetected disease among family members.
Oral and laryngeal cancer families will also be recruited in a manner similar to that described for NPC families, in an attempt to elucidate genetic factors linked to the development of these two cancers....
Read the detailed description
Nasopharyngeal carcinoma is a rare tumor among Caucasians that occurs with high incidence among individuals of Chinese descent. The disease is believed to have a multifactorial etiology with genetic, viral, and other environmental factors being involved. Little is known, however, about the genetic component of this disease.
We previously completed a case-control study of NPC in Taiwan. Using information obtained from the NPC cases recruited into this NCI-sponsored case-control study and parallel sources, we have been able to identify 250 families with multiple family members affected with NPC.
The purpose of the study described herein is to determine the role of inherited genetic factors in the etiology of NPC and to examine the effect of these genetic susceptibility factors on risk associated with environmental exposures.
Families will initially be contacted via an affected proband. Subsequently, informative family members will be asked to visit the study clinic to participate in the study. A family history questionnaire will be administered to the proband and other affected family members from each of the families selected for study. In addition, a risk factor questionnaire will be administered to all participating family members, and 30-40 ml of blood and an oral sample will be obtained from each study participant. Additional study components include medical record review to verify the diagnosis of NPC, retrieval of tumor tissue blocks as a source of DNA for study, and clinical exams on a sample of unaffected individuals to exclude the possibility of prevalent, undetected disease among family members.
Oral and laryngeal cancer families will also be recruited in a manner similar to that described for NPC families, in an attempt to elucidate genetic factors linked to the development of these two cancers.
- Conditions
- Nasopharyngeal Neoplasms, Herpesvirus 4, Human
- Keywords
- EBV, NPC
- Medical subject headings
- Nasopharyngeal Neoplasms, Epstein-Barr Virus Infections
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 |
|---|---|---|
| 1 | This is a high risk population of families for NPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasopharyngeal Carcinoma
Nasopharyngeal carcinoma diagnosis
Measured: Ongoing
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 start7 Nov 1995
- Primary completion31 May 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 3,795 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
- NCT00342147
- Sponsor's protocol ID
- 999995046
- Other IDs
- OH95-C-N046
- Status last verified
- Dec 2020
- First submitted
- 19 Jun 2006
- Last updated
- 11 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Study of Head and Neck Cancers in Taiwan
- ClinicalTrials.gov ID
- NCT00342147
- Acronym / sponsor ID
- 999995046
- Conditions
- Nasopharyngeal Neoplasms, Herpesvirus 4, Human
- Keywords
- EBV, NPC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,795 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 7 Nov 1995 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 5 Jun 2020 (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.
Nasopharyngeal carcinoma is a rare tumor among Caucasians which occurs with high incidence among individuals of Chinese descent. The disease is believed to have a multifactorial etiology with genetic, viral, and other environmental factors being involved. Little is known, however, about the genetic component of this disease.
We have recently completed subject recruitment for a case-control study of NPC in Taiwan. Using information obtained from the NPC cases recruited into this NCI-sponsored case-control study as well as from a parallel cross-sectional study conducted by our Taiwanese collaborators, we have been able to identify 120-150 families with multiple family members affected with NPC.
The purpose of the study described herein is to determine the role of inherited genetic factors in the etiology of NPC and to examine the effect of these genetic susceptibility factors on risk associated with environmental exposures.
Families will initially be contacted via the proband who previously participated in our case-control and cross-sectional studies. Subsequently, informative family members will be asked to visit the study clinic to participate in the study. A family history questionnaire will be administered to the proband from each of the families selected for study. In addition, a risk factor questionnaire will be administered to all participating family members, and 30-40 ml of blood and an oral sample will be obtained from each study participant. Additional study components include medical record review to verify the diagnosis of NPC, retrieval of tumor tissue blocks as a source of DNA for study, and clinical exams on a sample of unaffected individuals to exclude the possibility of prevalent, undetected disease among family members.
Oral and laryngeal cancer families will also be recruited in a manner similar to that described for NPC families, in an attempt to elucidate genetic factors linked to the development of these two cancers....
Detailed description
Nasopharyngeal carcinoma is a rare tumor among Caucasians that occurs with high incidence among individuals of Chinese descent. The disease is believed to have a multifactorial etiology with genetic, viral, and other environmental factors being involved. Little is known, however, about the genetic component of this disease.
We previously completed a case-control study of NPC in Taiwan. Using information obtained from the NPC cases recruited into this NCI-sponsored case-control study and parallel sources, we have been able to identify 250 families with multiple family members affected with NPC.
The purpose of the study described herein is to determine the role of inherited genetic factors in the etiology of NPC and to examine the effect of these genetic susceptibility factors on risk associated with environmental exposures.
Families will initially be contacted via an affected proband. Subsequently, informative family members will be asked to visit the study clinic to participate in the study. A family history questionnaire will be administered to the proband and other affected family members from each of the families selected for study. In addition, a risk factor questionnaire will be administered to all participating family members, and 30-40 ml of blood and an oral sample will be obtained from each study participant. Additional study components include medical record review to verify the diagnosis of NPC, retrieval of tumor tissue blocks as a source of DNA for study, and clinical exams on a sample of unaffected individuals to exclude the possibility of prevalent, undetected disease among family members.
Oral and laryngeal cancer families will also be recruited in a manner similar to that described for NPC families, in an attempt to elucidate genetic factors linked to the development of these two cancers.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –This is a high risk population of families for NPC |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a high risk population of families for NPC
Key inclusion criteria (2 listed)
- Subjects with head and neck cancer who are participants in the case-control study of NPC or the parallel studies of head and neck cancers conducted by the Taiwanese.
- Subjects who report one or more first degree family members affected with NPC, oral cancer, or laryngeal cancer.
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
Nasopharyngeal Carcinoma
Time frame: Ongoing
Nasopharyngeal carcinoma diagnosis
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 11 Dec 2020.
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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 and Herpesvirus 4, Human, 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 2 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: finished, as of the sponsor's last update on 11 Dec 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?
Nasopharyngeal Carcinoma (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.