Lung Cancer Clinical Trial
Official title:
Gene Polymorphisms and Symptoms in Lung Cancer Patients
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 (e.g., stage of disease, location of tumor), clinical health status (e.g.,
performance status, comorbid conditions), and sociodemographic characteristics (e.g.,
age, sex, race) for predicting the risk of severe and persistent symptoms.
Analytical aim: To determine if symptoms (e.g., fatigue, depression, lack of appetite) will
differ in severity by IL-6 gene polymorphisms (-174G/C, -597G/A, -572G/C, -373An/Tn).
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.
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.
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