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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

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ClinicalTrials.gov Identifier: NCT02146170
Recruitment Status : Recruiting
First Posted : May 23, 2014
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

- 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.

Objective:

- To collect tissue samples for use in the study of lung cancers.

Eligibility:

- 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.

Design:

  • 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

Detailed Description:

PRECIS

Background:

  • 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.

Objectives:

- 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).

Eligibility:

  • 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.

Design:

  • 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
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort
Single group
Patients with histologically or cytologically confirmed SCLC, SCLC, ESCC, PNET, and TET



Primary Outcome Measures :
  1. Allow sample acquisition for use in the study of thoracic malignancies except mesothelioma. [ Time Frame: Ongoing ]
    blood, tumor, body fluids, and normal tissue samples


Secondary Outcome Measures :
  1. Follow the natural history of patients with thoracic malignancies. [ Time Frame: Ongoing ]
    clinical data, including overall survival

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with histologically or cytologically confirmed NSCLC, SCLC, ESCC, PNET, and TET
Criteria
  • INCLUSION CRITERIA:
  • 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 to18 years. Children are excluded from the study, as the above thoracic malignancies are rare in this population.
  • Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

  • Active symptomatic major organ disorder that would increase the risk of biopsy, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction.
  • Active concomitant medical or psychological illnesses that may increase the risk to the subject, at the discretion of the principal investigator.
  • HIV-positive patients on combination antiretroviral therapy are ineligible.

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 ClinicalTrials.gov identifier (NCT number): NCT02146170


Contacts
Contact: Shannon G Swift, R.N. (240) 858-3157 shannon.swift@nih.gov
Contact: Udayan Guha, M.D. (240) 760-6115 udayan.guha@nih.gov

Locations
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      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Udayan Guha, M.D. National Cancer Institute (NCI)

Additional Information:
Publications:
Weir BA, Woo MS, Getz G, Perner S, Ding L, Beroukhim R, Lin WM, Province MA, Kraja A, Johnson LA, Shah K, Sato M, Thomas RK, Barletta JA, Borecki IB, Broderick S, Chang AC, Chiang DY, Chirieac LR, Cho J, Fujii Y, Gazdar AF, Giordano T, Greulich H, Hanna M, Johnson BE, Kris MG, Lash A, Lin L, Lindeman N, Mardis ER, McPherson JD, Minna JD, Morgan MB, Nadel M, Orringer MB, Osborne JR, Ozenberger B, Ramos AH, Robinson J, Roth JA, Rusch V, Sasaki H, Shepherd F, Sougnez C, Spitz MR, Tsao MS, Twomey D, Verhaak RG, Weinstock GM, Wheeler DA, Winckler W, Yoshizawa A, Yu S, Zakowski MF, Zhang Q, Beer DG, Wistuba II, Watson MA, Garraway LA, Ladanyi M, Travis WD, Pao W, Rubin MA, Gabriel SB, Gibbs RA, Varmus HE, Wilson RK, Lander ES, Meyerson M. Characterizing the cancer genome in lung adenocarcinoma. Nature. 2007 Dec 6;450(7171):893-8. Epub 2007 Nov 4.

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02146170     History of Changes
Other Study ID Numbers: 140105
14-C-0105
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 17, 2018

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) ):
Sample Acquisition
Generic and Epigenetic Alterations
Mig6 Expression
Proteomic Analysis
Genomic Analysis

Additional relevant MeSH terms:
Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Neuroendocrine Tumors
Neoplasms, Glandular and Epithelial
Thymus Neoplasms
Carcinoma, Small Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Lymphatic Diseases
Carcinoma