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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Department of Defense |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00352391 |
Purpose
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).
Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer Lung Cancer |
Other: Assessments |
Phase II |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| 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 |
Samples of lung tissue, saliva, blood, and scrapings from inside of cheek. Fluid and mucous collected during bronchoscopies.
| Estimated Enrollment: | 63 |
| Study Start Date: | August 2004 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Patients with Head and Neck or Non-Small Cell Lung Cancer who are Current or Former Smokers.
|
Other: Assessments
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.
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with a prior history of a definitively treated stage I/II head and neck or non-small cell lung cancer who are current or former smokers.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Waun K. Hong, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00352391 History of Changes |
| Other Study ID Numbers: | 2003-0424 |
| Study First Received: | July 12, 2006 |
| Last Updated: | September 2, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Non-Small Cell Lung Cancer Head And Neck Cancer Lung Cancer Bronchoscopy Laryngoscopy |
NSCLC Disease Free Survival Current Smoker Former Smoker |
|
Carcinoma, Non-Small-Cell Lung Head and Neck Neoplasms Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |