Prospective Screening for Patient Specific Genotypes and Phenotypes That Influence Drug Dosing and Trial Selection in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- To provide pharmacogenomic and/or biomarker analysis to support enrollment of patients on clinical trials that require such markers prior to enrollment.
研究概览
简要总结
Background:
People's genetic markers and other genetic characteristics can affect their response to drug therapy. Researchers want to screen people for these markers and characteristics. They want to do this before the people are screened for studies at the National Cancer Institute. That should save time that can be lost when people go through the whole screening for a study only to find out they cannot join. The data collected may also be used to select the proper dose of anticancer agents that are being studied.
Objective:
To screen people for genetic markers and/or baseline characteristics. These will be used to determine if they can enroll in a clinical trial. They may also be used to select the proper dose of anticancer agents that are being tested.
Eligibility:
Adults 18 and older who are being considered for or being treated in a National Cancer Institute study
Design:
Participants will have their blood drawn for genetic tests.
Some participants will have a cheek swab.
Participants genetic data will be stored for future research. It could be shared with other researchers.
详细描述
Background:
Genetic sequence of drug-metabolizing enzymes, transporters/receptors, transcription factors, drug targets, and patient baseline characteristics often affect an individual s response to drug therapy. Expression of such genes is also influenced by the epigenome and regulation by a variety of other factors: RNA expression, protein expression, disease state, comorbidities, concomitant therapies, etc. Therefore, inter-patient variability in drug pharmacokinetics and outcome is often a function of these factors.
Inter-individual differences in efficacy and toxicity of cancer chemotherapy are especially important given the narrow therapeutic index of these drugs.
During analysis of investigational agents, inter-individual variability in pharmacokinetics, pharmacodynamics, clinical outcome, and toxicity are often noted. Many of these differences are potentially clinically actionable and depend on the aforementioned markers.
Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •INCLUSION CRITERIA:
- •Any patient who is being evaluated for and/or treated on an IRB-approved protocol at the National Cancer Institute.
- •Age >18 years.
- •Ability of subject to understand and the willingness to sign a written informed consent document.
排除标准
- •- A patient will be excluded if there is an insufficient quality or quantity of sample available to perform the assay and no further sample can be drawn in order to re-assess the status of a genetic or biomarker.
研究组 & 干预措施
all patients
all eligible patients
结局指标
主要结局
To provide pharmacogenomic and/or biomarker analysis to support enrollment of patients on clinical trials that require such markers prior to enrollment.
时间窗: duration of study
Collection of 6 mL of peripheral blood to analyzed via DMET Plus kit for pathway genotype of enzymes and transporters with putative relevance for the drug of interest.
次要结局
未报告次要终点