iCare for Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Overall Response
研究概览
简要总结
The purpose of this study is to use genomic information from individual patients to create simulation avatars that will be used to predict novel drug combinations with therapeutic potential.
详细描述
As part of normal clinical care, subjects will undergo peripheral blood draws and biopsies for disease assessment of their cancer. In cases of hematological malignancies, bone marrow aspiration & biopsy are routinely performed.
As part of this project, the following will be done to the samples collected and with clinical outcomes data:
- donate peripheral blood specimens whenever blood is already being drawn for clinical purposes.
- donate bone marrow aspiration samples whenever a bone marrow aspiration procedure is already being done for clinical purposes.
- donate saliva whenever blood draw is already being done for clinical purposes.
- allow the investigators to perform gene mutation profiling.
- allow the investigators to study gene mutation results.
- allow the investigators to perform pharmacogenetic profiling.
- allow the investigators to study pharmacogenetic profiles.
- allow the investigators to examine chromosome copy number variations.
- allow the investigators to examine genomic methylation.
- allow the investigators to quantify metabolomics/cytokines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Individuals known or suspected of having a blood cancer or hematologic disorder
- •Individuals with presence of extramedullary disease
- •Capable of providing informed consent.
排除标准
- •Does not have a blood cancer or a hematologic disorder
研究组 & 干预措施
Acute Myeloid Leukemia
Patients with acute myeloid leukemia will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.
干预措施: Molecular diagnostic testing (Genetic)
Acute Lymphoblastic Leukemia
Patients with acute lymphoblastic leukemia will have blood, bone marrow aspirate , and saliva collected from them as part of routine care.
干预措施: Molecular diagnostic testing (Genetic)
Myelodysplastic Syndrome
Patients with myeloplastic syndrome will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.
干预措施: Molecular diagnostic testing (Genetic)
Myelofibrosis
Patients with myelofibrosis will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.
干预措施: Molecular diagnostic testing (Genetic)
Multiple Myeloma
Patients with multiple myeloma will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.
干预措施: Molecular diagnostic testing (Genetic)
结局指标
主要结局
Overall Response
时间窗: Up to 5 years
The overall response rate (ORR) is defined as achieving a complete remission (CR), partial remission (PR), and/or hematological improvement based on 2006 International Working Group (IWG) criteria (Cheson, et al. Blood 2006).
次要结局
- Overall survival after treatment(Up to 5 years)
- Number of patients with drug-related Grade 3 and Grade 4 adverse events(Up to 5 years)
- Progression-free survival after treatment(Up to five years)