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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Individuals consulted in the Clinical Center without a definitive diagnosis, but clinically considered likely to have a 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.

Disqualifiers

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 individuals not on combination antiretroviral therapy are ineligible.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 1 trial group
Group A: Single group

Trial outcomes

Primary outcomes

1

Allow sample acquisition for use in the study of thoracic malignancies except mesothelioma.

blood, tumor, body fluids, and normal tissue samples

Time frame
Ongoing

Secondary outcomes

1

Follow the natural history of patients with thoracic malignancies.

clinical data, including overall survival

Time frame
ongoing
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 ...

Specific studies include, but not limited to genomic analyses using NGS technologies (exome, transcriptome and/or whole genome sequencing), DNA methylation analyses, DNA copy number analyses, proteomic studies including mass spectrometry, capillary Westerns, reverse phase protein microarrays (RPPA), luminex assays, ELISA and IHC, and metabolomics studies using mass spectrometry.

Time frame
ongoing

Other outcomes

Sponsors and contacts

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