非小细胞肺癌、小细胞肺癌、肺外小细胞癌、肺神经内分泌肿瘤和胸腺上皮肿瘤患者的组织获取和自然史研究
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.
研究概览
详细说明
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:
- 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 biospecimen 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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Shannon G Swift, R.N.
- 电话号码:(240) 858-3157
- 邮箱:shannon.swift@nih.gov
研究联系人备份
- 姓名:Arun Rajan, M.D.
- 电话号码:(240) 760-6236
- 邮箱:rajana@mail.nih.gov
学习地点
-
-
Maryland
-
Bethesda、Maryland、美国、20892
- 招聘中
- National Institutes of Health Clinical Center
-
接触:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- 电话号码:TTY dial 711 800-411-1222
- 邮箱:ccopr@nih.gov
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients with histologically or cytologically confirmed NSCLC, SCLC, ESCC, PNET, and TET
描述
- 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.
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 individuals not on combination antiretroviral therapy are ineligible.
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:PROSPECTIVE
队列和干预
团体/队列 |
|---|
|
Single group
Patients with histologically or cytologically confirmed NSCLC, SCLC, ESCC, PNET, and TET |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Allow sample acquisition for use in the study of thoracic malignancies except mesothelioma.
大体时间:Ongoing
|
blood, tumor, body fluids, and normal tissue samples |
Ongoing
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Follow the natural history of patients with thoracic malignancies.
大体时间:ongoing
|
clinical data, including overall survival |
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 ...
大体时间:ongoing
|
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. |
ongoing
|
合作者和调查者
调查人员
- 首席研究员:Arun Rajan, M.D.、National Cancer Institute (NCI)
出版物和有用的链接
一般刊物
- 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. doi: 10.1038/nature06358. Epub 2007 Nov 4.
- Imielinski M, Berger AH, Hammerman PS, Hernandez B, Pugh TJ, Hodis E, Cho J, Suh J, Capelletti M, Sivachenko A, Sougnez C, Auclair D, Lawrence MS, Stojanov P, Cibulskis K, Choi K, de Waal L, Sharifnia T, Brooks A, Greulich H, Banerji S, Zander T, Seidel D, Leenders F, Ansen S, Ludwig C, Engel-Riedel W, Stoelben E, Wolf J, Goparju C, Thompson K, Winckler W, Kwiatkowski D, Johnson BE, Janne PA, Miller VA, Pao W, Travis WD, Pass HI, Gabriel SB, Lander ES, Thomas RK, Garraway LA, Getz G, Meyerson M. Mapping the hallmarks of lung adenocarcinoma with massively parallel sequencing. Cell. 2012 Sep 14;150(6):1107-20. doi: 10.1016/j.cell.2012.08.029.
- Rikova K, Guo A, Zeng Q, Possemato A, Yu J, Haack H, Nardone J, Lee K, Reeves C, Li Y, Hu Y, Tan Z, Stokes M, Sullivan L, Mitchell J, Wetzel R, Macneill J, Ren JM, Yuan J, Bakalarski CE, Villen J, Kornhauser JM, Smith B, Li D, Zhou X, Gygi SP, Gu TL, Polakiewicz RD, Rush J, Comb MJ. Global survey of phosphotyrosine signaling identifies oncogenic kinases in lung cancer. Cell. 2007 Dec 14;131(6):1190-203. doi: 10.1016/j.cell.2007.11.025.
- Wong-Rolle A, Dong Q, Zhu Y, Divakar P, Hor JL, Kedei N, Wong M, Tillo D, Conner EA, Rajan A, Schrump DS, Jin C, Germain RN, Zhao C. Spatial meta-transcriptomics reveal associations of intratumor bacteria burden with lung cancer cells showing a distinct oncogenic signature. J Immunother Cancer. 2022 Jul;10(7):e004698. doi: 10.1136/jitc-2022-004698.
- Fialkoff G, Takahashi N, Sharkia I, Gutin J, Hermoni N, Nirula M, Kumar R, Pongor L, Nichols S, Sciuto L, Parmar K, Desai P, Suresh P, Abel M, El Meskini R, Maoz M, Rottenberg Y, Nevo S, Nechushtan H, Peretz T, Roame D, Hubert A, Cohen JE, Salah A, Temper M, Grinshpun A, Weaver-Ohler Z, Rajan A, Figg WD Sr, Zick A, Sadeh R, Friedman N, Thomas A. Plasma nucleosome profiling reports on tumor burden and molecular subtypes in small cell lung cancer. J Clin Invest. 2026 Oct 1;136(19):e202151. doi: 10.1172/JCI202151. eCollection 2026 Oct 1.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 140105
- 14-C-0105
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
IPD 共享时间框架
Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
IPD 共享访问标准
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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