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
Conditions
Non-Small Cell Lung Cancer - Small Cell Lung Cancer - Extrapulmonary Small Cell Cancer - Pulmonary Neuroendocrine Tumors - Thymic Epithelial Tumors
Conditions: official terms
Apudoma - Carcinoid Tumor - Carcinoma, Non-Small-Cell Lung - Carcinoma, Small Cell - Lung Neoplasms - Neoplasms - Neoplasms, Glandular and Epithelial - Neuroendocrine Tumors - Small Cell Lung Carcinoma - Thymus Neoplasms
Conditions: Keywords
Sample Acquisition, Generic and Epigenetic Alterations, Mig6 Expression, Proteomic Analysis, Genomic Analysis
Study Type
Observational
Study Phase
N/A
Study Design
Time Perspective: Prospective
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 or the subject s Legally Authorized Representative to understand and the willingness to sign a written informed consent document.

- Pregnant or breast feeding women will be eligible for this protocol, but will not undergo tumor biopsy.

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.
Location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Status: Recruiting
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office - 888-624-1937
Start Date
April 2014
Completion Date
April 2025
Sponsors
National Cancer Institute (NCI)
Source
National Institutes of Health Clinical Center (CC)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page