Family Study of Head and Neck Cancers in Taiwan

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00342147
Collaborator
(none)
3,795
1
294.9
12.9

Study Details

Study Description

Brief 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. 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 or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    3795 participants
    Observational Model:
    Family-Based
    Time Perspective:
    Prospective
    Official Title:
    Family Study of Head and Neck Cancers in Taiwan
    Actual Study Start Date :
    Nov 7, 1995
    Actual Primary Completion Date :
    May 31, 2020
    Actual Study Completion Date :
    Jun 5, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    1

    This is a high risk population of families for NPC

    Outcome Measures

    Primary Outcome Measures

    1. Nasopharyngeal Carcinoma [Ongoing]

      Nasopharyngeal carcinoma diagnosis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • 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

    Locations

    Site City State Country Postal Code
    1 National Taiwan University College of Medicine Taipei, Taiwan China

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Allan Hildesheim, Ph.D., National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00342147
    Other Study ID Numbers:
    • 999995046
    • OH95-C-N046
    First Posted:
    Jun 21, 2006
    Last Update Posted:
    Dec 11, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Cancer Institute (NCI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 11, 2020