Mesothelioma Related Clinical Trials:
Prospective Evaluation of Epigenetic Alterations in Patients With Lung and Esophageal Cancers and Malignant Pleural Mesotheliomas

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Status: Recruiting
Sponsors and Collaborators: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00447447

Condition: Esophageal Cancer; Lung Cancer; Malignant Mesothelioma
Intervention: Procedure: DNA methylation analysis; Procedure: bronchoalveolar lavage; Procedure: bronchoscopy; Procedure: diagnostic procedure; Procedure: endoscopic biopsy; Procedure: gene expression analysis;Procedure: needle biopsy

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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, or malignant pleural mesothelioma.

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.

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.

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Eligibility:

Ages Eligible for Study:   18 Years and older
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, 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

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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    

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Additional Information:

Study ID Numbers:   CDR0000456443, NCI-06-C-0014, NCI-P6650
First Received:   March 13, 2007
Last Updated:   December 25, 2007
ClinicalTrials.gov Identifier:   NCT00447447
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
advanced malignant mesothelioma  
localized malignant mesothelioma  
recurrent malignant mesothelioma  
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

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

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Digestive System Diseases
Neoplasms by Site
Neoplasms by Histologic Type
Mesothelioma
Respiratory Tract Diseases
Neoplasms, Mesothelial

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