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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00122239
Recruitment Status : Unknown
Verified March 2016 by AHS Cancer Control Alberta.
Recruitment status was:  Active, not recruiting
First Posted : July 22, 2005
Last Update Posted : March 16, 2016
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

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.

Condition or disease
Breast Cancer Glioma Prostate Cancer Carcinoma, Squamous Cell Carcinoma, Non-Small-Cell-Lung Head and Neck Cancer

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.

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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 : January 2005
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be selected consecutively if they have undergone a course of radical radiotherapy.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00122239

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Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
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Principal Investigator: Matthew Parliament, MD Cross Cancer Institute
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Responsible Party: AHS Cancer Control Alberta Identifier: NCT00122239    
Other Study ID Numbers: SP-14-0043 / ethics 21725
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Keywords provided by AHS Cancer Control Alberta:
radiation toxicity
single nucleotide polymorphism
breast carcinoma
prostate carcinoma
squamous cell carcinoma of the head and neck
lung carcinoma (non-small cell)
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Radiation Injuries
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Squamous Cell
Wounds and Injuries