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ATM Variants in Radiotherapy Patients

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT00214227
Collaborator
(none)
60
Enrollment
1
Location
61
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the baseline incidence of variant alleles in the ATM and/or other DNA repair genes present in the Native American population versus the non-Native American population. It is thought that a higher baseline incidence of the variant alleles in the ATM gene may correlate to higher rates and higher grades of radiation toxicities noted in the Native American population.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    ATM Variants in Radiotherapy
    Study Start Date :
    Dec 1, 2007
    Actual Primary Completion Date :
    Jan 1, 2013
    Actual Study Completion Date :
    Jan 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. to determine baseline incidence of variant alleles in ATM [one blood draw]

      to determine the baseline incidence of variant alleles in ATM resent in the population of Native americans with cancer who are undergoing radiation therapy to a similar group of non-native americans who have undergone or are undergoing raditohterapy

    Secondary Outcome Measures

    1. to compare the baseline incidence of variant alleles in ATM [one blood draw]

      to compare the baseline incidence of variant alleles in ATM resent in the population of Native americans with cancer who are undergoing radiation therapy to a similar group of non-native americans who have undergone or are undergoing raditohterapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Indication for radiotherapy.

    • Ability or desire to donate a blood sample and be followed closely for radiation toxicities

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792

    Sponsors and Collaborators

    • University of Wisconsin, Madison

    Investigators

    • Principal Investigator: Mark Ritter, MD, PhD, University of Wisconsin, Madison

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT00214227
    Other Study ID Numbers:
    • RO05305
    • 2005-0122
    • A533300
    • SMPH/HUMAN ONCOLOGY
    First Posted:
    Sep 21, 2005
    Last Update Posted:
    Nov 19, 2019
    Last Verified:
    Jun 1, 2013
    Keywords provided by University of Wisconsin, Madison
    patient who will undergo definitive radiotherapy

    Study Results

    No Results Posted as of Nov 19, 2019