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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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.
  • - Known HIV-positive patients on combination antiretroviral therapy are ineligible.
  • - Pregnant women are ineligible.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02146170
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Arun Rajan, M.D.
Principal Investigator Affiliation National Cancer Institute (NCI)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Extrapulmonary Small Cell Cancer, Pulmonary Neuroendocrine Tumors, Thymic Epithelial Tumors
Study Website: View Trial Website
Additional Details

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 procedures, which may include a tumor biopsy, bone marrow biopsy or the collection of blood, urine or other body fluids.
  • - An accrual ceiling of 2000 subjects is planned over an accrual period of 10 years.

Arms & Interventions

Arms

: Single group

Patients with histologically or cytologically confirmed NSCLC, SCLC, ESCC, PNET, and TET

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

Site Contact

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

ccopr@nih.gov

800-411-1222 #TTY dial 711

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