Vanguard Study for Head and Neck Cancer or Non-Small Cell Lung Cancer (NSCLC) Patients
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|ClinicalTrials.gov Identifier: NCT00352391|
Recruitment Status : Completed
First Posted : July 14, 2006
Last Update Posted : February 3, 2016
The goal of this research study is to look at how long individuals who have been treated for early stage NSCLC or HNSCC live without developing lung cancer. Another goal is to develop tools to help predict the likelihood of lung cancer occurrence in this population. This will be done by studying characteristics of tissue and bodily fluids (including blood).
- To assess the smoking-related disease-free survival in patients who are current or former smokers with a prior definitively-treated stage I/II lung or head and neck cancer.
- To develop a risk model to help predict the likelihood of lung cancer development both imaging and biomarker based in this high-risk population.
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer Lung Cancer||Other: Assessments|
|Study Type :||Observational|
|Actual Enrollment :||54 participants|
|Official Title:||Vanguard Study Characterizing Occurrence of Recurrent or Second Primary Tumors in Patients With Prior History of Definitively Treated Stage I/II Head and Neck or Non-Small Cell Lung Cancer Who Are Current or Former Smokers|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Patients with Head and Neck or Non-Small Cell Lung Cancer who are Current or Former Smokers.
At Months 6, 12, 18, 24, 30, and 36, complete medical history will be recorded, and a physical exam will be performed by either a doctor or a nurse. At each of these visits, blood will be drawn for routine tests (about 3 teaspoons) and for research purposes (about 4 teaspoons). Also, a chest x-ray and a chest CT will be done at these visits.
- Smoking-Related Disease-Free Survival (S-DFS) [ Time Frame: 6 Years ]Smoking-related disease-free survival (S-DFS) defined as time from registration to the development of recurrence, smoking related SPT, or disease-specific death, whichever occurs first.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352391
|United States, Georgia|
|Eisenhower Army Medical Center|
|Fort Gordon, Georgia, United States, 30905|
|United States, Pennsylvania|
|Conemaugh Memorial Medical Center|
|Johnstown, Pennsylvania, United States, 15901|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||George Simon, MD||M.D. Anderson Cancer Center|