Evaluation of Cell Changes in Blood and Tissue in Cancers of the Lung, Esophagus and Lung Lining

This study is currently recruiting participants.
Verified October 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00242723
First received: October 20, 2005
Last updated: March 14, 2014
Last verified: October 2013
  Purpose

Background:

  • Chromatin is is the structural building block of a chromosome. It is found inside the nucleus of the cell and consists of a complex of DNA and protein.
  • Cancers of the lung, pleura (lung lining) and esophagus show profound changes in chromatin structure that may affect the course of disease in patients.
  • A better understanding of these diseases and the genetic changes associated with them may be helpful in developing new treatments for them.

Objectives:

  • To evaluate people with cancer of the lung, pleura or esophagus for participation in NCI clinical trials.
  • To obtain biopsies (small pieces of tissue) from tumor, normal tissue and blood samples to learn more about the cellular changes in blood and tissue in tumors of the lung, esophagus and pleura and surrounding structures in the chest.

Eligibility: Patients 18 years of age and older with cancer of the lung, esophagus, pleura, mediastinum or chest wall, or cancers of other origin that have invaded the lung.

Design:

  • Up to 800 patients may be included in this study.
  • Patients undergo standard tests for evaluating the stage of their disease and for determining eligibility for an NCI investigational treatment study.
  • All patients undergo bronchoscopy and bronchoalveolar lavage ("washing" with salt water) to assess their tumor and collect a sample of normal tissue. Patients whose tumor is located on the outside portion of the lung may also undergo thoracoscopy to obtain a tumor sample. For bronchoscopy and bronchoalveolar lavage a tube with a light is passed through the nose or mouth into the lungs to examine the airways. Salt water is injected through the tube and then withdrawn to obtain cells for laboratory studies. For the thoracoscopy a small tube with a light is put through a small hole in the chest to obtain the tumor sample. Both procedures are usually done under general anesthesia. The tissue is examined to identify cell characteristics of people who respond to certain therapies and to identify markers on the surface of the tissue that may be useful in future research and treatment.
  • Blood and urine samples are collected from patients.
  • Patients who are eligible for a treatment study at NCI are offered participation in the study.
  • Patients for whom standard surgery, radiation or chemotherapy is more appropriate may receive treatment at NCI or with their own physician.
  • Patients who receive treatment at NCI return for follow-up examinations 4 weeks after discharge and then every 2 to 4 months depending on the nature of their cancer.

Condition
Thoracic Malignancy
Lung Cancer
Esophageal Cancer
Malignant Pleural Mesothelioma

Study Type: Observational
Official Title: Prospective Evaluation of Epigenetic Alterations in Patients With Thoracic Malignancies

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 800
Study Start Date: October 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patients with potentially malignant or suspicious lesions, or with biopsy proven lung cancers or esophageal cancers, malignant pleural mesotheliomas, mediastinal or chest wall neoplasms, thymoma/thymic carcinomas, or thoracic metastases from cancers of non-thoracic origin.

Patients must have an ECOG performance score of 0-2.

Patients must be 18 years of age or older. Patients under 18 years of age may participate if the tissue acquisition is performed during a clinically indicated surgical procedure, and the sampling of tissue, blood and urine does not add risk to the clinically indicated procedures.

Patients must be aware of the neoplastic nature of his/her illness. The patient or parent must be willing to sign an Informed Consent, and undergo endoscopic biopsies of tumor and adjacent normal tissues, and provide blood (30cc) and urine (100cc) samples to support ongoing laboratory research endeavors pertaining to the epigenetics of thoracic malignancies.

EXCLUSION CRITERIA:

Candidates who do not meet the inclusion criteria

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242723

Contacts
Contact: Tricia Kunst, R.N. (301) 451-1233 kunstt@mail.nih.gov
Contact: David S Schrump, M.D. (301) 496-2128 david_schrump@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: David S Schrump, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00242723     History of Changes
Obsolete Identifiers: NCT00447447
Other Study ID Numbers: 060014, 06-C-0014
Study First Received: October 20, 2005
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Lung Cancers
Esophageal Cancer
Malignant Pleural Mesothelioma
Biopsy
Staging Studies
Lung Cancer

Additional relevant MeSH terms:
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Lung Diseases
Respiratory Tract Diseases
Neoplasms
Esophageal Neoplasms
Lung Neoplasms
Mesothelioma
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on April 17, 2014