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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 : August 9, 2022
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 2 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. Note: Patients >= 2 years of age and under 18 years of age may only participate in research sample collection.


  • Up to 1100 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
Malignant Pleural Mesotheliomas NOS Esophageal Cancers NOS Lung Cancer NOS Thoracic Cancers Cancers of Non Thoracic Origin With Metastases to the Lungs or Pleura

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 1100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Genetic and Epigenetic Alterations in Patients With Thoracic Malignancies
Actual Study Start Date : November 9, 2005

Resource links provided by the National Library of Medicine

1/Cohort 1
Subjects with potentially malignant or suspicious lesions, or biopsy proven thoracic cancers or thoracic metastases from cancers of non-thoracic origin

Primary Outcome Measures :
  1. to obtain specimens for research [ Time Frame: open-ended ]
    specimens for research

  2. permit evaluation of patients referred to the Thoracic Surgery Branch, NCI in order to identify individuals who will be suitable candidates for treatment/intervention protocols [ Time Frame: open ended ]
    evaluation of patients referred to the Thoracic Surgery Branch, NCI in order to identify individuals who will be suitable candidates for treatment/intervention research protocols

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.

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary clinical@@@

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 2 years of age or older. Note: Patients >= 2 and < 18 years of age may participate in research sample collection 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 nature of his/her illness. The patient must be willing to undergo standard intervention that may include endoscopic biopsies of tumor and adjacent normal tissues, and to provide blood and urine samples to support ongoing laboratory research endeavors pertaining to the epigenetics of thoracic malignancies.

Ability of subject, their parents/guardians 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

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Contact: Deneise Francis, R.N. (240) 858-3974
Contact: David S Schrump, M.D. (240) 760-6239

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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711   
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: David S Schrump, M.D. National Cancer Institute (NCI)
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00242723    
Obsolete Identifiers: NCT00447447
Other Study ID Numbers: 060014
First Posted: October 20, 2005    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: July 19, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Staging Studies
potentially malignant or suspicious lesions
Cancer Primary Evaluation
Lung Cancer
Esophageal Cancer
Malignant Pleural Mesothelioma
Additional relevant MeSH terms:
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Esophageal Neoplasms
Mesothelioma, Malignant
Lung 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
Pleural Neoplasms