Gene Polymorphisms and Symptoms in Lung Cancer Patients

Lung Cancer Clinical Trial

Official title:

Gene Polymorphisms and Symptoms in Lung Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00504374
• Other study ID #: 2006-0273
• Secondary ID: CA109043
• Status: Completed
• Start date: June 13, 2006
• Est. completion date: April 27, 2017

Study information

• Verified date: May 2019
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: April 27, 2017
• Est. primary completion date: April 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Questionnaire
Symptoms questionnaire lasting about 5 to 10 minutes.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)

External Links

•   University of Texas MD Anderson Cancer Center Website