A Study of Gene Polymorphisms and Normal Tissue Radiation Injury in Patients Treated for Breast, Prostate, Brain, Lung, and Head and Neck Cancers

Sponsor
AHS Cancer Control Alberta (Other)
Overall Status
Unknown status
CT.gov ID
NCT00122239
Collaborator
Cross Cancer Institute (Other)
13
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145
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Study Details

Study Description

Brief Summary

This study will examine, for the first time, the independent contribution of a patient's own genetic makeup to the development of post-radiation complications, permitting the future development of predictive tests to avoid radiation injury. To do this, the investigators will examine gene markers in a series of breast, prostate, brain and lung cancer survivors who have received conformal radiotherapy between 1996 and 2003 at the Cross Cancer Institute and Tom Baker Cancer Centre.

Detailed Description

Major innovations in radiotherapy (RT) delivery (3D conformal RT, intensity modulated RT) now permit RT dose escalation to be tested as a means of improving disease control in many tumour sites. With delivery innovations, life-threatening toxicity occurs rarely, but significant clinical toxicity is common. In previous work the investigators have studied a cohort of 98 prostate patients who received dose-escalated 3D-CRT and have obtained evidence of genetic and dosimetric factors underlying rectal/bladder toxicity. They posit that the late radiation toxicity disease state has significant genetic determinants in other malignancies. These determinants are neither understood nor accounted for in selection of treatment, and the investigators propose to study additional well-characterized cohorts, who are clinically well from a disease control perspective, given that comprehensive dosimetric and outcome information is available on all.

For a thorough understanding of the molecular processes underlying tissue responses to radiation damage, the investigators propose a genomic analysis. Their working hypothesis is that normal organ toxicity will be associated with patient genetics as measured by single nucleotide polymorphisms (SNPs) in a select group of genes. The criteria for selecting SNPs will be based on a candidate gene approach, choosing genes implicated or demonstrated in DNA repair pathways and radiation-induced tissue damage/tissue homeostasis. Analysis of these data will use both statistically based bioinformatics approaches.

Study Design

Study Type:
Observational
Actual Enrollment :
13 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
A Study of Gene Polymorphisms and Normal Tissue Radiation Injury in Patients Treated for Breast, Prostate, Brain, Lung, and Head and Neck Cancers
Study Start Date :
Jan 1, 2005
Anticipated Primary Completion Date :
Feb 1, 2017
Anticipated Study Completion Date :
Feb 1, 2017

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Breast cancer

    • Prostate cancer

    • Squamous cell carcinoma (SCC) of the head and neck

    • Non-small-cell-lung carcinoma (NSCLC)

    • Glioma treated by radiotherapy

    Exclusion Criteria:
    • Follow-up less than 18 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2

    Sponsors and Collaborators

    • AHS Cancer Control Alberta
    • Cross Cancer Institute

    Investigators

    • Principal Investigator: Matthew Parliament, MD, Cross Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AHS Cancer Control Alberta
    ClinicalTrials.gov Identifier:
    NCT00122239
    Other Study ID Numbers:
    • SP-14-0043 / ethics 21725
    First Posted:
    Jul 22, 2005
    Last Update Posted:
    Mar 16, 2016
    Last Verified:
    Mar 1, 2016

    Study Results

    No Results Posted as of Mar 16, 2016