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 |
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Recruitment Status :
Recruiting
First Posted : October 20, 2005
Last Update Posted : December 6, 2018
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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 Salt water is injected through the tube and then withdrawn to obtain cells for laboratory studies.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 or disease |
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| 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: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Prospective Evaluation of Epigenetic Alterations in Patients With Thoracic Malignancies |
| Study Start Date : | October 18, 2005 |
| Group/Cohort |
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1/Cohort 1
Subjects with potentially malignant or suspicious lesions, or biopsy proven thoracic cancers or thoracic metastases from cancers of non-thoracic origin
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- 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
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| Ages Eligible for Study: | up to 100 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
- 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 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.
EXCLUSION CRITERIA:
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) 760-6234 | kunstt@mail.nih.gov | |
| Contact: David S Schrump, M.D. | (240) 760-6239 | david_schrump@nih.gov |
| 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) |
Additional Information:
Publications:
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00242723 History of Changes |
| Obsolete Identifiers: | NCT00447447 |
| Other Study ID Numbers: |
060014 06-C-0014 |
| First Posted: | October 20, 2005 Key Record Dates |
| Last Update Posted: | December 6, 2018 |
| Last Verified: | June 29, 2018 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
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Lung Cancers Esophageal Cancer Malignant Pleural Mesothelioma |
Biopsy Staging Studies Lung Cancer |
Additional relevant MeSH terms:
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Lung Neoplasms Esophageal Neoplasms Mesothelioma 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 Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Mesothelial |