- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00214227
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
-
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Wisconsin
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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.
Sponsor
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.
Helpful Links
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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