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Study of Patients With Non-Small Cell Lung Cancer, Esophageal Cancer, Malignant Pleural Mesothelioma, Mediastinal or Chest Wall Neoplasms, or Lung Metastases From Cancers of Non-Thoracic Origin
This study is currently recruiting participants.
Study NCT00447447   Information provided by National Cancer Institute (NCI)
First Received: March 13, 2007   Last Updated: February 6, 2009   History of Changes

March 13, 2007
February 6, 2009
November 2005
 
  • Identification of patients who are suitable candidates for clinical research protocols [ Designated as safety issue: No ]
  • Biopsies [ Designated as safety issue: No ]
  • Identification of patients who are suitable candidates for clinical research protocols
  • Biopsies
Complete list of historical versions of study NCT00447447 on ClinicalTrials.gov Archive Site
 
 
 
Study of Patients With Non-Small Cell Lung Cancer, Esophageal Cancer, Malignant Pleural Mesothelioma, Mediastinal or Chest Wall Neoplasms, or Lung Metastases From Cancers of Non-Thoracic Origin
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, malignant pleural mesothelioma, mediastinal or chest wall neoplasms, or lung metastases from cancers of non-thoracic origin.

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.
  • Permit long-term follow up of patients with thoracic malignancies, including the collection of tissue and fluids to support preclinical research, particularly to ascertain if gene expression and DNA methylation profiles coincide with response to therapy.

OUTLINE: This is a prospective study.

Patients undergo bronchoscopy. Tumor tissue and normal tissue are collected via endoscopy, fine-needle aspiration, core-needle techniques, or single-port site thoracoscopic methods. Biopsies 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.

 
Interventional
Primary Purpose:  Diagnostic
  • Esophageal Cancer
  • Lung Cancer
  • Malignant Mesothelioma
  • Metastatic Cancer
  • Genetic: DNA methylation analysis
  • Genetic: gene expression analysis
  • Procedure: bronchoscopy
  • Procedure: endoscopic biopsy
  • Procedure: needle biopsy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
375
 
 

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed or radiographic evidence of primary non-small cell lung cancer, esophageal cancer, malignant pleural mesothelioma, mediastinal or chest wall neoplasms, or pulmonary metastases from cancers of non-thoracic origin
  • Intracranial metastases potentially treatable with surgery and/or radiotherapy allowed

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • ANC ≥ 1,000/mm³
  • Platelet count ≥ 75,000/mm³
  • PT ≤ 16 OR INR ≤ 2
  • Creatinine < 2.5 g/dL
  • Bilirubin ≤ 2 times upper limit of normal

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
 
No
 
United States
 
NCT00447447
 
CDR0000456443, NCI-06-C-0014, NCI-P6650
National Cancer Institute (NCI)
 
Study Chair: David S. Schrump, MD NCI - Surgery Branch
National Cancer Institute (NCI)
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP