Tissue Procurement and Natural History Study of People With Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Extrapulmonary Small Cell Cancer, Pulmonary Neuroendocrine Tumors, and Thymic Epithelial Tumors
|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.|
|ClinicalTrials.gov Identifier: NCT02146170|
Recruitment Status : Recruiting
First Posted : May 23, 2014
Last Update Posted : October 22, 2018
- Lung cancer is the leading cause of cancer-related death worldwide. It causes more than one million deaths every year. Researchers want to gather tissue samples from people with lung and thymic cancers to understand the disease better. This may lead to new ways to diagnose and treat it.
- To collect tissue samples for use in the study of lung cancers.
- Adults over age 18 with non-small cell lung cancer, small cell lung cancer, extra pulmonary small cell cancer, pulmonary neuroendocrine tumors, and thymic epithelial tumors.
- Participants will be screened with a medical history, physical exam, and blood tests. They will be asked about how they perform their daily tasks.
- Participants may be asked to give urine and blood samples. They may give a saliva sample if they cannot give blood. They will also give a sample of their tumor from a biopsy they had. They may also be given the option to undergo a biopsy.
- Participants may have MRI, CT, and/or PET scans of the body. They will lie in a machine that takes pictures of the body.
- After visits to the Clinical Center end, researchers will contact participants by phone every year to check on their health.
|Condition or disease|
|Non-Small Cell Lung Cancer Small Cell Lung Cancer Extrapulmonary Small Cell Cancer Pulmonary Neuroendocrine Tumors Thymic Epithelial Tumors|
- Lung cancer is the leading cause of cancer-related death worldwide, accounting for more than one million deaths every year.
- Several genetic and epigenetic alterations are involved in initiation and progression of NSCLC. Some of these alterations are seen in normal and preneoplastic cells as well, suggesting a sequential development from normal epithelial cells to cancer, through a multistep process, usually coincident with cigarette smoking.
- This natural history protocol is an extension of our Molecular Profiling protocol to enable tissue collection for more in-depth proteomic and genomic analyses to understand tumor biology and treatment response.
- A cohort of patients enrolled in this natural history study is likely to enroll in the IRB approved protocol for end-of-life in-patient hospice and rapid autopsy following death (13-C0131). Longitudinally collected tumor tissue from these patients, including from several metastatic sites at autopsy will be a unique resource to understand tumor evolution.
- There will be opportunity to embark upon a wide array of studies in the future with the longitudinally collected tissue samples tagged with clinical information from patients.
- To allow sample acquisition for use in the study of non-small cell lung cancer (NSCLC), Small cell lung cancer (SCLC), extrapulmonary small cell cancer (ESCC), pulmonary neuroendocrine tumors (PNET), and thymic epithelial tumors (TETs).
- Patients with histologically or cytologically confirmed NSCLC, SCLC, ESCC, PNET, and TET.
- Patients consulted in the Clinical Center without a definitive diagnosis, but clinically considered likely to have a thoracic malignancy of the above histologies, pending further tissue acquisition and/or pathology review.
- Age greater than or equal to 18 years.
- This is a bio-specimen collection and natural history protocol in which samples will be collected from patients with NSCLC, SCLC, ESCC, PNET, and TET.
- Eligible patients undergoing screening for or participating in NIH protocols or eligible patients treated elsewhere and referred from other oncologists will be referred for participation in this study.
- Upon providing informed consent, patients will undergo sample acquisition procedure, which may include a tumor biopsy, blood, urine, abnormal body fluid and a cheek swab collection.
- An accrual ceiling of 2000 subjects is planned over an accrual period of 10 years.
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Tissue Procurement and Natural History Study of Patients With Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Extrapulmonary Small Cell Cancer, Pulmonary Neuroendocrine Tumors, and Thymic Epithelial Tumors|
|Study Start Date :||May 8, 2014|
|Estimated Primary Completion Date :||April 30, 2024|
|Estimated Study Completion Date :||April 30, 2025|
Patients with histologically or cytologically confirmed SCLC, SCLC, ESCC, PNET, and TET
- Allow sample acquisition for use in the study of thoracic malignancies except mesothelioma. [ Time Frame: Ongoing ]blood, tumor, body fluids, and normal tissue samples
- Follow the natural history of patients with thoracic malignancies. [ Time Frame: Ongoing ]clinical data, including overall survival
- Conduct genomic, proteomic and immunological analyses on blood, tumor, body fluid and normal tissue in support of NIH translational trials to develop new therapeutic agents and novel treatment approaches as well as new prognostic and diagnostic ... [ Time Frame: Ongoing ]Specific studies include, but not limited to genomic analyses usingNGS technologies (exome, transcriptome and/or whole genomesequencing), DNA methylation analyses, DNA copy numberanalyses, proteomic studies including mass spectrometry, capillary Westerns, reverse phase protein microarrays (RPPA), luminex assays, ELISA and IHC, and metabolomics studies using mass spectrometry.
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): NCT02146170
|Contact: Shannon G Swift, R.N.||(240) email@example.com|
|Contact: Udayan Guha, 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 888-624-1937|
|Principal Investigator:||Udayan Guha, M.D.||National Cancer Institute (NCI)|