Evaluation of Cell Changes in Blood and Tissue in Cancers of the Lung, Esophagus and Lung Lining
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|ClinicalTrials.gov Identifier: NCT00242723|
Recruitment Status : Recruiting
First Posted : October 20, 2005
Last Update Posted : December 11, 2020
- 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 Salt water is injected through the tube and then withdrawn to obtain cells for laboratory studies.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|
|Study Type :||Observational|
|Estimated Enrollment :||1100 participants|
|Official Title:||Prospective Evaluation of Epigenetic Alterations in Patients With Thoracic Malignancies|
|Actual Study Start Date :||November 9, 2005|
Subjects with potentially malignant or suspicious lesions, or biopsy proven thoracic cancers or thoracic metastases from cancers of non-thoracic origin
- 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 ]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
- To obtain specimens for research [ Time Frame: Open Ended ]specimens for research
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 ClinicalTrials.gov identifier (NCT number): NCT00242723
|Contact: Tricia Kunst, R.N.||(240) email@example.com|
|Contact: David S Schrump, M.D.||(240) firstname.lastname@example.org|
|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|
|Principal Investigator:||David S Schrump, M.D.||National Cancer Institute (NCI)|