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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00242723
Recruitment Status : Recruiting
First Posted : October 20, 2005
Last Update Posted : May 23, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


  • 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.


  • 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.


  • 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 Salt water is injected through the tube and then withdrawn to obtain cells for laboratory studies.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 or disease
Pulmonary Metastases From Cancers Mediastinal or Chest Wall Neoplasms Malignant Pleural Mesotheliomas NOS Esophageal Cancers NOS Lung Cancer NOS

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of Epigenetic Alterations in Patients With Thoracic Malignancies
Study Start Date : October 18, 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Permit evaluation of patients referred to the Thoracic Surgery Section, of the Thoracic and GI Malignancies Branch, NCI in order to identify individuals who will be suitable candidates for clinical research protocols [ Time Frame: Open Ended ]
  2. To obtain specimens for research [ Time Frame: Open Ended ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 must be willing to 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.

Ability of subject or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00242723

Contact: Tricia Kunst, R.N. (240) 760-6234
Contact: David S Schrump, M.D. (240) 760-6239

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
National Cancer Institute (NCI)
Principal Investigator: David S Schrump, M.D. National Cancer Institute (NCI)

Additional Information:
Responsible Party: National Cancer Institute (NCI) Identifier: NCT00242723     History of Changes
Obsolete Identifiers: NCT00447447
Other Study ID Numbers: 060014
First Posted: October 20, 2005    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 3, 2018

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

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