Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122239
Status:
UNKNOWN
Last Update Posted:
2016-03-16
First Post:
2005-07-20
Brief Title:
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
Organization:
AHS Cancer Control Alberta
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine for the first time the independent contribution of a patients 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 rectalbladder 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 damagetissue homeostasis Analysis of these data will use both statistically based bioinformatics approaches
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 damagetissue homeostasis Analysis of these data will use both statistically based bioinformatics approaches
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None