Lung Cancer Clinical Trial; Gene Polymorphisms and Symptoms in Lung Cancer Patients

Gene Polymorphisms and Symptoms in Lung Cancer Patients
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, September 2008
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00504374

Purpose
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.

Condition Intervention
Lung Cancer
Behavioral: Questionnaire

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Gene Polymorphisms and Symptoms in Lung Cancer Patients

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
To gain a better understanding of certain symptoms (such as pain, lack of appetite, lack of energy) patients with lung cancer may have as a result of cancer treatment. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
To find out if there are certain biological characteristics (such as certain genes) that may cause symptoms to be more severe and to last longer. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:
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.

Estimated Enrollment: 320
Study Start Date: June 2006
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
1
Patients with lung cancer. Behavioral: Questionnaire
Symptoms questionnaire lasting about 5 to 10 minutes.

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.

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population
Patients with lung cancer.

Criteria
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.
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504374

Contacts
Contact: Cielito C. Reyes-Gibby, DrPH 713-792-3020

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Cielito C. Reyes-Gibby, DrPH

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Cielito C. Reyes-Gibby, DrPH U.T. M.D. Anderson Cancer Center

More Information

UT MD Anderson Cancer Center Website

Responsible Party: U.T.M.D. Anderson Cancer Center ( Cielito C. Reyes-Gibby, DrPH/Assistant Professor )
Study ID Numbers: 2006-0273
Study First Received: July 19, 2007
Last Updated: September 29, 2008
ClinicalTrials.gov Identifier: NCT00504374 [history]
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Lung Cancer
Epidemiology
Symptoms
Gene Polymorphisms
Questionnaire
Survey

Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms

ClinicalTrials.gov processed this record on February 10, 2009

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