Collection and Storage of Blood and Tissue Samples From Patients Who Are Undergoing Surgery For Lung Cancer
2022年8月2日 更新者：Alliance for Clinical Trials in Oncology
The CALGB Lung Cancer Tissue Bank
This research studies collecting and storing tissue and blood samples from patients with lung cancer who are undergoing surgery.
Collecting and storing samples of tissue and blood from patients with lung cancer to study in the laboratory may help doctors learn more about changes that may occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.
研究概览
详细说明
OBJECTIVES:
- To collect, catalog and store frozen samples of lung carcinoma and when possible, portions of involved lymph nodes, as well as adjacent grossly uninvolved lung tissue obtained from surgical specimens of patients undergoing surgical resection for previously untreated lung cancer as a source of quality DNA, messenger ribonucleic acid (mRNA) and protein for molecular analysis.
- To collect, catalog and store frozen samples of blood pre- and post-resection from the same patients to provide a source of reference DNA to assess somatic mutations associated with tumor or preneoplastic "normal" lung, and to allow assessment of levels of circulating markers.
- To associate these specimens with historical, clinical, pathological, and outcome information.
Grossly viable tumor and grossly normal lung tissue are identified and removed from patient surgical specimens and cryopreserved until shipment to the Cancer and Leukemia Group B (CALGB) Lung Cancer Tissue Bank for future use in research. Blood specimens are also collected prior to surgery and at 4-12 weeks post-surgery (before the start of adjuvant therapy) and shipped immediately to the Tissue Bank.
研究类型
观察性的
注册 (预期的)
500
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Delaware
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Lewes、Delaware、美国、19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark、Delaware、美国、19713
- CCOP - Christiana Care Health Services
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Maryland
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Elkton、Maryland、美国、21921
- Union Hospital of Cecil County
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Massachusetts
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Boston、Massachusetts、美国、02115
- Dana-Farber/Brigham and Women's Cancer Center
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Boston、Massachusetts、美国、02115
- Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
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Minnesota
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Minneapolis、Minnesota、美国、55455
- Masonic Cancer Center at University of Minnesota
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Missouri
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Columbia、Missouri、美国、65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Saint Louis、Missouri、美国、63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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New Jersey
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Voorhees、New Jersey、美国、08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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Buffalo、New York、美国、14263-0001
- Roswell Park Cancer Institute
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Syracuse、New York、美国、13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Asheville、North Carolina、美国、28805
- Veterans Affairs Medical Center - Asheville
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Durham、North Carolina、美国、27710
- Duke Cancer Institute
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Pennsylvania
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Monroeville、Pennsylvania、美国、15146
- Forbes Regional Hospital
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Natrona Heights、Pennsylvania、美国、15065
- Alle-Kiski Medical Center
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Pittsburgh、Pennsylvania、美国、15212
- Allegheny Cancer Center at Allegheny General Hospital
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Rhode Island
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Providence、Rhode Island、美国、02906
- Miriam Hospital
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Providence、Rhode Island、美国、02903
- Rhode Island Hospital Comprehensive Cancer Center
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Vermont
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Burlington、Vermont、美国、05401
- Fletcher Allen Health Care - University Health Center Campus
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients with suspected or histologically documented previously untreated lung cancer undergoing surgical resection at a CALGB Lung Cancer Tissue Bank-approved institution.
描述
- Histologic Documentation: All patients with suspected or histologically documented previously untreated lung cancer undergoing surgical resection are eligible whether or not the patient participates in a CALGB-sponsored treatment trial; patients enrolled on a CALGB trial of preoperative chemotherapy for lung cancer will be eligible if a pre-treatment frozen sample of tumor (e.g., a positive lymph node from mediastinoscopy) can be submitted to the bank; patients enrolled on CALGB 140203, intraoperative sentinel node mapping in non-small cell lung cancer, are not eligible.
- No patients with known infectious disease, such as human immunodeficiency virus (HIV), tuberculosis (TB), or hepatitis B, C
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：仅案例
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Ancillary-Correlative (lung cancer tissue bank)
Grossly viable tumor and grossly normal lung tissue are identified and removed from patient surgical specimens and cryopreserved until shipment to the CALGB Lung Cancer Tissue Bank for future use in research.
Blood specimens are also collected prior to surgery and at 4-12 weeks post-surgery (before the start of adjuvant therapy) and shipped immediately to the Tissue Bank.
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correlative studies
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Collection and storage of frozen tissue samples for molecular analysisor resection of lung cancer
大体时间：Up to 5 years
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Up to 5 years
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Collection and storage of frozen blood samples for the assessment of somatic mutations and levels of circulating markersto assess levels of circulating markers
大体时间：Up to 5 years
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Up to 5 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：William Richards, MD、Brigham and Women's Cancer Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2004年7月15日
初级完成 (实际的)
2022年1月1日
研究完成 (实际的)
2022年2月15日
研究注册日期
首次提交
2009年5月9日
首先提交符合 QC 标准的
2009年5月9日
首次发布 (估计)
2009年5月12日
研究记录更新
最后更新发布 (实际的)
2022年8月3日
上次提交的符合 QC 标准的更新
2022年8月2日
最后验证
2022年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.