NCT00214227

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.2 years until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 19, 2019

Status Verified

June 1, 2013

Enrollment Period

5.1 years

First QC Date

September 13, 2005

Last Update Submit

November 15, 2019

Conditions

Radiotherapy

Keywords

patient who will undergo definitive radiotherapy

Outcome Measures

Primary Outcomes (1)

  • to determine baseline incidence of variant alleles in ATM

    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 Outcomes (1)

  • to compare the baseline incidence of variant alleles in ATM

    one blood draw

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been enrolled on RO02803.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Links

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.

Study Officials

  • Mark Ritter, MD, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

December 1, 2007

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 19, 2019

Record last verified: 2013-06

Locations

US(1)