Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504374
Status:
COMPLETED
Last Update Posted:
2019-06-04
First Post:
2007-07-19
Brief Title:
Gene Polymorphisms and Symptoms in Lung Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Gene Polymorphisms and Symptoms in Lung Cancer Patients
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
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:
Primary Objectives
Construct a prospective cohort of patients diagnosed with lung cancer and dispositioned for treatment and collect information on symptoms and symptom treatments at baseline and on follow-up
Develop preliminary statistical models incorporating genetic data which will be obtained from an existing protocol CPN 91-001 Margaret Spitz disease-related variables eg stage of disease location of tumor clinical health status eg performance status comorbid conditions and sociodemographic characteristics eg age sex race for predicting the risk of severe and persistent symptoms
Analytical aim To determine if symptoms eg fatigue depression lack of appetite will differ in severity by IL-6 gene polymorphisms -174GC -597GA -572GC -373AnTn
This study NIH-CA109043 Reyes-Gibby 2004-2009 builds upon an NIH-funded NIH-CA55769 Spitz 2003-2008 study of the molecular epidemiology of lung cancer
Construct a prospective cohort of patients diagnosed with lung cancer and dispositioned for treatment and collect information on symptoms and symptom treatments at baseline and on follow-up
Develop preliminary statistical models incorporating genetic data which will be obtained from an existing protocol CPN 91-001 Margaret Spitz disease-related variables eg stage of disease location of tumor clinical health status eg performance status comorbid conditions and sociodemographic characteristics eg age sex race for predicting the risk of severe and persistent symptoms
Analytical aim To determine if symptoms eg fatigue depression lack of appetite will differ in severity by IL-6 gene polymorphisms -174GC -597GA -572GC -373AnTn
This study NIH-CA109043 Reyes-Gibby 2004-2009 builds upon an NIH-funded NIH-CA55769 Spitz 2003-2008 study of the molecular epidemiology of lung cancer
Detailed Description:
If you agree to take part in this study upon being admitted for treatment you will be asked about your symptoms how severe they are and to what degree they affect your day-to-day functioning
You will be asked to fill out a symptoms questionnaire each time you are at the clinic for your treatment and for your follow-up visits The questionnaire will take about 5 to 10 minutes to complete each time
You may also be contacted at home so that researchers can follow-up on your experience with symptoms only if you are not able to come to the clinic for your chemoradiation treatment or follow-up visits If you are contacted by phone the call should last about 5 to 10 minutes each time
Researchers will also try to collect some of your leftover blood that was already drawn and stored for research studies from a previous lung cancer study Ecogenetics of Lung Cancer that you participated in at M D Anderson Researchers will use your leftover blood sample to look at certain genes in your blood that may affect your symptoms If you did not have blood collected in the previous lung cancer study you will have a blood sample one tablespoon drawn when you first agree to participate in this study
This is an investigational study Up to 320 patients will take part in this study All will be enrolled at M D Anderson
You will be asked to fill out a symptoms questionnaire each time you are at the clinic for your treatment and for your follow-up visits The questionnaire will take about 5 to 10 minutes to complete each time
You may also be contacted at home so that researchers can follow-up on your experience with symptoms only if you are not able to come to the clinic for your chemoradiation treatment or follow-up visits If you are contacted by phone the call should last about 5 to 10 minutes each time
Researchers will also try to collect some of your leftover blood that was already drawn and stored for research studies from a previous lung cancer study Ecogenetics of Lung Cancer that you participated in at M D Anderson Researchers will use your leftover blood sample to look at certain genes in your blood that may affect your symptoms If you did not have blood collected in the previous lung cancer study you will have a blood sample one tablespoon drawn when you first agree to participate in this study
This is an investigational study Up to 320 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CA109043 | OTHER_GRANT | NCI | None |