Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

ATM Variants in Radiotherapy Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214227
First received: September 13, 2005
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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
Radiotherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ATM Variants in Radiotherapy

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • to determine baseline incidence of variant alleles in ATM [ Time Frame: one blood draw ] [ Designated as safety issue: No ]
    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:
  • to compare the baseline incidence of variant alleles in ATM [ Time Frame: one blood draw ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples With DNA

direct sequence analysis of all exons and intron-exon junctions of the ATM gene. DNA will be isolated from lympocytes using the PAX blood DNA system.


Enrollment: 60
Study Start Date: December 2007
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have been enrolled on RO02803.

Criteria

Inclusion Criteria:

  • Indication for radiotherapy.
  • Ability or desire to donate a blood sample and be followed closely for radiation toxicities
  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: NCT00214227

Locations
United States, Wisconsin
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
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214227     History of Changes
Other Study ID Numbers: RO05305
Study First Received: September 13, 2005
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
patient who will undergo definitive radiotherapy

ClinicalTrials.gov processed this record on November 20, 2014