Full Text View
Tabular View
No Study Results Posted
Related Studies
A Study of Gene Polymorphisms and Normal Tissue Radiation Injury in Patients Treated for Breast, Prostate, Brain, Lung, and Head and Neck Cancers
This study is currently recruiting participants.
Study NCT00122239   Information provided by Alberta Cancer Board
First Received: July 20, 2005   Last Updated: April 10, 2007   History of Changes

July 20, 2005
April 10, 2007
January 2005
 
 
 
Complete list of historical versions of study NCT00122239 on ClinicalTrials.gov Archive Site
 
 
 
A Study of Gene Polymorphisms and Normal Tissue Radiation Injury in Patients Treated for Breast, Prostate, Brain, Lung, and Head and Neck Cancers
A Study of Gene Polymorphisms and Normal Tissue Radiation Injury in Patients Treated for Breast, Prostate, Brain, Lung, and Head and Neck Cancers

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.

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.

 
Observational
Natural History, Cross-Sectional, Defined Population, Retrospective Study
  • Breast Cancer
  • Glioma
  • Prostate Cancer
  • Carcinoma, Squamous Cell
  • Carcinoma, Non-Small-Cell-Lung
  • Head and Neck Cancer
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
500
 
 

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
Both
 
No
Contact: Matthew Parliament, MD 780-432-8517 matthewp@cancerboard.ab.ca
Canada
 
NCT00122239
 
SP-14-0043
Alberta Cancer Board
 
Principal Investigator: Matthew Parliament, MD Cross Cancer Institute
Alberta Cancer Board
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP