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 - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00447447

Purpose

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.

Condition	Intervention
Esophageal Cancer Lung Cancer Malignant Mesothelioma Metastatic Cancer	Procedure: DNA methylation analysis Procedure: bronchoscopy Procedure: endoscopic biopsy Procedure: gene expression analysis Procedure: needle biopsy

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Lung Cancer Mesothelioma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	Prospective Evaluation of Epigenetic Alterations in Patients With Lung and Esophageal Cancers and Malignant Pleural Mesotheliomas

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Identification of patients who are suitable candidates for clinical research protocols [ Designated as safety issue: No ]
Biopsies [ Designated as safety issue: No ]

Estimated Enrollment:	375
Study Start Date:	November 2005

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447447

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

David S. Schrump, MD

NCI - Surgery Branch

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Web site for additional information This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000456443, NCI-06-C-0014, NCI-P6650
Study First Received:	March 13, 2007
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00447447
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent non-small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent esophageal cancer
stage I esophageal cancer

stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer
advanced malignant mesothelioma
localized malignant mesothelioma
recurrent malignant mesothelioma
lung metastases

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Recurrence
Carcinoma
Digestive System Diseases
Respiratory Tract Diseases
Lung Neoplasms

Head and Neck Neoplasms
Lung Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Mesothelioma
Esophageal Diseases
Esophageal neoplasm
Adenoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes

Neoplasms by Site
Neoplasms by Histologic Type
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on January 16, 2009