Family Study of Head and Neck Cancers in Taiwan

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00342147
First received: June 19, 2006
Last updated: September 5, 2014
Last verified: July 2014
  Purpose

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.


Condition
Nasopharyngeal Neoplasms
Herpesvirus 4, Human

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Family Study of Head and Neck Cancers in Taiwan

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Nasopharyngeal Carcinoma [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: November 1995
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00342147

Locations
China
National Taiwan University College of Medicine
Taipei, Taiwan, China
Sponsors and Collaborators
Investigators
Principal Investigator: Allan Hildesheim, Ph.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00342147     History of Changes
Other Study ID Numbers: 999995046, OH95-C-N046
Study First Received: June 19, 2006
Last Updated: September 5, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
EBV
NPC

Additional relevant MeSH terms:
Head and Neck Neoplasms
Nasopharyngeal Neoplasms
Nasopharyngeal Diseases
Neoplasms
Neoplasms by Site
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 30, 2014