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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient has lung cancer and is being treated at M. D. Anderson.
At least 18 years of age
Currently living in the United States
Enrolled in CPN 91-001 (Molecular epidemiology of lung cancer)
English or Spanish speaking

Exclusion criteria

Patient is unable to understand the intent of the study.

Treatment and study plan

Questionnaire

Behavioral

Symptoms questionnaire lasting about 5 to 10 minutes.

Other names: Survey

Primary outcomes

Patient Symptom Severity (MD Anderson Symptom Inventory Questionnaire)

Time frame: Baseline (before), during (every week for 6 weeks), and after chemoradiation therapy (at 6-12 week intervals)

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Important dates

Study start: 2006
Primary completion: 2017
Study completion: 2017
First posted: Jul 20, 2007
Registry last updated: Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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