MDACC Study Summary 2006-0273

Study Summary
No. 2006-0273:.......Lung......Cielito C. Reyes-Gibby......Epidemiology

Study Summary Title



Study Summary Number:	2006-0273

Study Title:	Gene polymorphisms and symptoms in lung cancer patients

Physician

New Patient Referral



Name:	Cielito C. Reyes-Gibby	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Epidemiology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-3020 Contact us about clinical trials

General Information



Disease Group:	Lung	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Subjects will complete MDASI before treatment, every week during their 6-week chemoradiation treatment, at restaging (usually 6 weeks post-treatment), and at their follow-up visit (usually 3 months post-treatment).

Treatment Agents:	None	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this psychosocial research study is 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. Researchers also want 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.

Study Objectives / Outcomes

1. 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.
2. 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.

Study Status Information



Study Activation / Registration Date:	06/13/2006

IRB Review and Approval Date:	06/13/2006

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patient has lung cancer and is being treated at M. D. Anderson.

2) At least 18 years of age

3) Currently living in the United States

4) Enrolled in CPN 91-001 (Molecular epidemiology of lung cancer)

5) English or Spanish speaking

Exclusion Criteria:

1) Patient is unable to understand the intent of the study.

Links

Registration Number: NCT00504374
Study Information on Clinical Trials Registry (clinicaltrials.gov)