朗格汉斯和非朗格汉斯细胞组织细胞肿瘤和 Castleman 病的分子基础
朗格汉斯细胞和非朗格汉斯细胞组织细胞肿瘤和 Castleman 病分子基础的探索性分析
The purpose of this study is to use agnostic genomic evaluation using whole exome sequencing (WES) of a variety of rare hematologic diseases grouped under rare blood diseases and its variants to further elucidate the understanding of the chemistry of these disorders and identify potential actionable mutations that can be targeted with therapies in the context of clinical trials.
研究概览
详细说明
The study team will examine genetic changes, also known as mutations, in the DNA of participants' blood, or if applicable, bone marrow specimen. These types of tests are increasingly used by doctors to improve the accuracy of diagnosis and make decisions during care. This study seeks to understand how many patients will benefit from this testing, and in what ways. The results of this portion of the study are placed in the individual's medical record and are communicated back to each participant.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Ohio
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Cleveland、Ohio、美国、44106-5065
- Cleveland Clinic, Case Comprehensive Cancer Center
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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
描述
Inclusion Criteria:
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Must have histopathologic confirmation of the particular rare hematologic disease.
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Diseases that will be considered as rare hematologic diseases for this study will include the following
- Langerhans cell histiocytosis (LCH)
- Erdhiem Chester disease (ECD)
- Rosai-Dorfman disease (RDD)
- Miscellaneous histiocytic entities -indeterminate dendritic cell tumor, interdigitating dendritic cell sarcoma, follicular dendritic cell sarcoma, fibroblastic reticular cell tumor
- Unicentric Castleman disease
- Multicentric Castleman disease including TAFRO
- Follicular Dendritic Cell sarcoma (FDCS)
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Newly diagnosed treatment naïve patients as well as patients who received prior therapies (e.g. chemotherapy, targeted therapy, surgery, or radiation) will be included. -Tissue specimens collected within the past 5 yearse will be considered acceptable for study inclusion will include the following
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Collected as part of the evaluation for diagnostic confirmation
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Tissue specimen or extracted DNA (from blood sample) banked in IRB approved tissue repositories and obtained within five years prior to the date of informed consent. -Tissue samples are planned to be collectedfrom previously stored surgical specimens already being stored in pathology lab
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Consent to have germline testing performed in parallel to tumor testingg)Patients willing to receive treatmen
Exclusion Criteria:
- Life expectancy of less than 6months
- Patient unwilling to have germline testing performed on peripheral blood or buccal mucosa
学习计划
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Genomic analysis
When a participant's disorder was diagnosed, blood or tissue specimen was collected. A part of the tissue or blood will be sent to an outside company, Tempus, to be tested for specific genetic changes and the results will be sent back to participants' physician. |
Genetic testing of blood or tissue sample and limited medical information sent to an outside company. Database will link genome sequence data with human trait information, including cancer and other diseases, to be sent to participant's physician. |
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 |
|---|---|---|
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Proportion of genomic analyses yielding genetic aberrations
大体时间：Up to 12 months from last participant accrued
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Proportion of genomic analyses yielding actionable genetic aberrations. "Actionable" is defined as a mutation linked to an approved therapy in the particular disease under study or another disease, a known or suspected contraindication to a given therapy, or a clinical trial linked to the alteration |
Up to 12 months from last participant accrued
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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基因组分析产生种系遗传畸变的比例
大体时间：从最后一位参与者算起最多 12 个月
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从最后一位参与者算起最多 12 个月
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Proportion of genomic analyses yielding actionable genetic aberrations
大体时间：Up to 12 months from last participant accrued
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Actionable will be defined as a mutation linked to an approved therapy in the particular disease or another disease, a known or suspected contraindication to a given therapy, or a clinical trial linked to the alteration. |
Up to 12 months from last participant accrued
|
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Referral rates for genetic counseling for germline mutations
大体时间：Up to 12 months from last participant accrued
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Number of participants with germline mutations who were referred to genetic counseling through Cancer Genetics for their identified germline mutations |
Up to 12 months from last participant accrued
|
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Completion rates of genetic counseling for germline mutations
大体时间：Up to 12 months from last participant accrued
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Number of participants with germline mutations who were referred to, and underwent (completed) genetic counseling through Cancer Genetics. |
Up to 12 months from last participant accrued
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合作者和调查者
调查人员
- 首席研究员：Sudipto Mukherjee, MD, PhD、Cleveland Clinic, Case Comprehensive Cancer Center
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 (实际的)
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
其他相关的 MeSH 术语
其他研究编号
- CASE7Z20
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
Deidentified IPD will be shared to maintain patient confidentiality
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
在美国制造并从美国出口的产品
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