Feasibility Clinical Study of Targeted and Genome-Wide Sequencing
2020年3月9日 更新者：University Health Network, Toronto
This research is being done to find out what types of gene mutations are present in people with cancer.
This study is designed to help researchers and doctors understand more about cancer.
With this information, doctors may have a better idea as to which cancer treatments are most appropriate for certain patients.
The information will also help researchers find out the how to identify genes in cancers from biopsies and blood samples and how to use this information to help doctors and patients make treatment decisions.
研究概览
详细说明
This is a prospective cohort study with the goal of obtaining fresh tumor biopsies and one blood sample from patients with a confirmed histological or cytological diagnosis of cancer, who are potential candidates for a phase I or II clinical trial at their local institution.
DNA from fresh tumor biopsies and from mononuclear blood cells will be subjected to targeted and genome-wide sequencing to enable molecular characterization of tumors.
Application of genomic information by investigators will be captured.
Archived tumor samples will be requested from all patients.
For patients with malignant ascites or pleural effusions, fluid and tumor samples will be evaluated.
研究类型
观察性的
注册 (实际的)
50
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
-
-
Ontario
-
Toronto、Ontario、加拿大、M5G 2M9
- Princess Margaret Hospital
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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
概率样本
研究人群
Patients from the Princess Margaret Hospital or other Ontario Institution
描述
Inclusion Criteria:
- Age > 18 years.
- Histological or cytological proof of solid tumour cancer.
- At least one biopsiable lesion deemed medically accessible and safe to biopsy.
- Candidate for one or more phase I or II clinical trials in the local institution or in another Ontario institution, at the time of study enrollment or at a later time point.
- Fulfills local institution's laboratory parameters for tumor biopsy.
- Willingness and ability of patient to provide signed voluntary informed consent.
Exclusion Criteria:
- Any condition that could interfere with their ability to provide informed consent such as dementia or severe cognitive impairment.
- Any contraindication to undergoing a biopsy procedure.
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Solid Tumor Cancer
|
Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)
|
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 |
|---|---|---|
|
Time From Patient Recruitment to Final Results ≤ 21 Days in ≥ 90% of Patients
大体时间：All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
|
Average and range of time (in calendar days) that occurred between study participants providing informed consent to the reporting of genomic results to the physician.
|
All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Actionable Genomic Results
大体时间：All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
|
Number of participants with actionable genomic results (defined as having the potential to impact on management recommendations based on diagnostic, prognostic and/or predictive implications), expressed as a percentage of the total number of study participants.
|
All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
|
|
Number of Participants With Adverse Events Due to Tumor Biopsies on Study
大体时间：All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
|
Number of participants with any adverse events possibly, probably or definitely related to tumor biopsies on study; Grading by CTCAE version 4 of adverse events.
|
All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
|
|
Patient and Physician Experience
大体时间：All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
|
Qualitative and quantitative responses on questionnaires and personal interviews regarding patient and physician experience of this research process and their understanding of genomic analysis including perceptions of benefit versus disadvantages, impact on clinical care and decision making
|
All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
|
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。
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)
2011年3月1日
初级完成 (实际的)
2013年3月25日
研究完成 (实际的)
2019年1月21日
研究注册日期
首次提交
2011年4月21日
首先提交符合 QC 标准的
2011年4月28日
首次发布 (估计)
2011年5月2日
研究记录更新
最后更新发布 (实际的)
2020年3月23日
上次提交的符合 QC 标准的更新
2020年3月9日
最后验证
2020年3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.