Official Title: “Prospective Evaluation of Epigenetic Alterations in Patients With Lung and Esophageal Cancers and Malignant Pleural Mesotheliomas”

RATIONALE: Collecting and storing samples of tissue, blood, and urine from patients with cancer to study in the laboratory may help the study of cancer. It may also help doctors identify patients who are eligible for clinical trials.

PURPOSE: This study is collecting and examining tissue, blood, and urine samples from patients with non-small cell lung cancer, esophageal cancer, or malignant pleural mesothelioma.

Study Type: Interventional

Study Design: Diagnostic

OBJECTIVES: - Evaluate patients referred to the Thoracic Oncology Section of the Surgery Branch, NCI in order to identify patients who are suitable candidates for clinical research protocols. - Obtain biopsies during staging studies of tumor and adjacent normal tissues as well as serum and urine samples from patients with primary aerodigestive tract malignancies to support preclinical research endeavors in the Thoracic Oncology Section. - Permit standard treatment for patients who are not eligible for investigational therapy on a current Thoracic Oncology protocol, but who present a novel and unique clinical training opportunity, or who manifest a clinical condition that requires immediate intervention to prevent compromise to the patient's well-being.

OUTLINE: This is a prospective study.

Patients undergo bronchoscopy and/or bronchoalveolar lavage (BAL). Tumor tissue and normal tissue are collected via endoscopy, fine-needle aspiration, core-needle techniques, or single-port site thoracoscopic methods. Biopsies and BAL fluids are examined for gene expression and DNA methylation analysis. Blood and urine are also collected.

PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.

Primary:

• Identification of patients who are suitable candidates for clinical research protocols No
• Biopsies No

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed or radiographic evidence of primary non-small cell lung cancer, esophageal cancer, or malignant pleural mesothelioma
• Intracranial metastases potentially treatable with surgery and/or radiotherapy allowed

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Normal coagulation parameters

PRIOR CONCURRENT THERAPY:

• Not specified

Lead Sponsor: National Cancer Institute (NCI)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda Maryland 20892-1182 United States

Overall Clinical Trial Officials and Contacts

David S. Schrump, MD Study Chair NCI - Surgery Branch  

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00447447

Study ID Number: CDR0000456443

ClinicalTrials.gov Identifier: NCT00447447

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database

Web site for additional information