Gene Polymorphisms and Symptoms in Lung Cancer Patients

NCT00504374 | Completed

• 2 other identifiers: 2006-0273CA109043
• Study Type: observational
• Target: 235
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Lung Cancer

Keywords

Lung Cancer; Epidemiology; Symptoms; Gene Polymorphisms; Questionnaire; Survey

Outcome Measures

Primary Outcomes (1)

• Patient Symptom Severity (MD Anderson Symptom Inventory Questionnaire)

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

Study Arms (1)

Symptoms Questionnaire

Patients with lung cancer.

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Symptoms questionnaire lasting about 5 to 10 minutes.

Also known as: Survey

Symptoms Questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lung cancer.

You may qualify if:

• 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

You may not qualify if:

• Patient is unable to understand the intent of the study.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Cielito C. Reyes-Gibby, DrPH

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 20, 2007
• Study Start: June 13, 2006
• Primary Completion: April 27, 2017
• Study Completion: April 27, 2017
• Last Updated: June 4, 2019

Record last verified: 2019-05

Locations

US (1)