ATM Variants in Radiotherapy Patients

November 15, 2019 updated by: University of Wisconsin, Madison

ATM Variants in Radiotherapy

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients who have been enrolled on RO02803.

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to determine baseline incidence of variant alleles in ATM
Time Frame: 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
one blood draw

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to compare the baseline incidence of variant alleles in ATM
Time Frame: 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
one blood draw

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

June 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • RO05305
  • A533300 (Other Identifier: UW Madison)
  • 2005-0122 (Other Identifier: Institutional Review Board)
  • SMPH/HUMAN ONCOLOGY (Other Identifier: UW Madison)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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