Biospecimen Acquisition From Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,750
- 试验地点
- 1
- 主要终点
- Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
研究概览
简要总结
This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate. This study does not involve treatment.
Participants will have about 50 ml (3 tablespoonfuls) of blood drawn. Depending on their condition, patients may be invited to enroll in a clinical research study involving chemotherapy, radiotherapy, or surgery. Additional 40-ml blood samples may be drawn during the course of treatment.
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详细描述
Background:
- Correlative studies performed on biospecimens of human subjects can be used to investigate the biology of solid tumors, inform the development of new strategies for treating those cancers, and evaluate these new therapeutic approaches. Specific areas of interest include, but are not limited to:
- the underlying mechanisms of tumor-specific immune response and suppression in cancer patients
- genetic and molecular profiling of tumors through circulating tumor cell (cTC), circulating DNA, and tissue analysis
- investigation of potential early diagnostic and prognostic indicators for solid tumors such as cTCs and miRNA expression of serum exosomes
- identification of mechanisms of drug-related adverse events and correlation with clinical parameters
- the role of commensal gut microbiota in both the innate and adaptive responses to tumors as well as with the use of anticancer agents
Objectives:
- Analyze biospecimens such as tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
- Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
- Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
Eligibility:
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
- 是
入选标准
- •INCLUSION CRITERIA:
- •Patients with a known or suspected malignancy and healthy volunteers 18 years of age and older are eligible.
- •Performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.
- •Ability to understand and the willingness to sign a written informed consent document.
- •INCLUSION FOR APHERESIS:
- •Note: Effective with Amendment CC, participants will no longer be asked to undergo apheresis. This content is being retained for historical reference.
- •Hemoglobin greater than or equal to 10 mg/dL and platelet count > 75,000/mm(3)
- •Weight greater than 25 kg
- •HIV negative
- •Prothrombin Time - within normal limits
- •Partial Thromboplastin Time - within normal limits
- •Medically indicated central line in place or adequate peripheral venous access
排除标准
- 未提供
研究组 & 干预措施
Healthy Volunteers
Healthy volunteers 18 years of age and older
Participants
Participants with cancer 18 years of age and older
结局指标
主要结局
Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
时间窗: ongoing
Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
Collection of tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
时间窗: ongoing
Analyze tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
时间窗: ongoing
Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
次要结局
未报告次要终点