NCT02146170招募中不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Allow sample acquisition for use in the study of thoracic malignancies except mesothelioma.
研究概览
简要总结
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.
详细描述
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 pre-neoplastic 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-C-0131). 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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •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.
排除标准
- •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.
研究组 & 干预措施
Single group
Patients with histologically or cytologically confirmed NSCLC, SCLC, ESCC, PNET, and TET
结局指标
主要结局
Allow sample acquisition for use in the study of thoracic malignancies except mesothelioma.
时间窗: Ongoing
blood, tumor, body fluids, and normal tissue samples
次要结局
- Follow the natural history of patients with thoracic malignancies.(ongoing)
- 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 ...(ongoing)
研究者
研究点 (1)
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