Collection of Blood From Therapeutic Trial Participants for Analysis of Genetic Differences in Drug Disposition and Pharmacokinetics of Probe Medications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Obtain and analyze the genomic DNA from patients with cancer, other tumors, or possible genetic tumor predisposition syndromes on a therapeutic clinical trial.
研究概览
简要总结
Background:
- Some genes may be associated with a greater chance of side effects during cancer treatment. These genes may also make certain treatments less effective. Researchers want to collect blood or cheek swab samples from people having cancer treatment to study these genes.
Objectives:
- To obtain a blood or cheek swab sample to study genetic differences that may affect cancer treatment.
Eligibility:
- Individuals with cancer who are being treated at the National Cancer Institute.
Design:
- Participants will provide a blood sample for study.
- Participants who have blood-based cancer, such as leukemia, will provide a cheek swab sample.
- If the blood or cheek swab sample does not have enough genetic material for analysis, an additional sample may be collected.
详细描述
Background:
- Genetic polymorphisms in drug-metabolizing enzymes, transporters/receptors might affect an individual's response to drug therapy.
- Inter-individual differences in efficacy and toxicity of antitumor agents are especially important given the narrow therapeutic index of these drugs.
- During analysis of investigational agents, inter-individual variation in pharmacokinetics (PK) and pharmacodynamics (PD) is most often noted. Genetic variation in genes encoding proteins that regulate or mediate the metabolism and transport of drugs often account for some of the wide variation seen in PK/PD, and ultimately the response to, and toxicity from, pharmaceutical agents.
- The administration of probe substrates can be used to determine the phenotype of enzymes and transporters responsible for drug disposition, providing a useful tool to better understand the cause of unexpected AEs or toxicities of clinical trial participants.
Objectives:
-Explore potential associations between genetic variants discovered with Pharmacoscan involved in inter-individual differences in drug disposition versus the pharmacokinetics, pharmacodynamics of pharmaceutical agents.
Eligibility:
研究设计
- 研究类型
- 观察性
- 观察模型
- 仅病例
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Any individual currently enrolled in an NIH intramural research program clinical trials receiving treatment.
- Ability of participant or Legally Authorized Representative (LAR) to understand and be willing to sign the informed consent document.
- Age >= 3 years old
排除标准
- N/A
研究组 & 干预措施
1/ Patients with cancer, other tumors, or possible genetic tumor
Patients enrolled on IRB approved NIH Intramural Research Program (IRP) therapeutic clinical trials
结局指标
主要结局
Obtain and analyze the genomic DNA from patients with cancer, other tumors, or possible genetic tumor predisposition syndromes on a therapeutic clinical trial.
时间窗: duration of study
to determine the association between SNP parameters and clinical response and/or toxicity from genomic DNA extracted from patient samples
次要结局
未报告次要终点
研究者
研究点 (1)
标识符
- NCT 编号
- NCT01441089
- 其他研究编号
- 110242, 11-C-0242
日期
- 首次提交
- (15年前)
- 首次发布
- (15年前)
- 最近核实
- (8个月前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
All collected IPD will be shared