Evaluation for NCI Surgery Branch Clinical Research Protocols
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- Frequency of HLA type, gene specific mutations, or expression of neoantigens in malignant tumors
研究概览
简要总结
Background:
The National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.
Objective:
This study will allow patients to under screening and evaluation for participation in NC-SB Protocols.
Eligibility:
Patients 18 years or older must meet the minimum eligibility criteria for an NCI-SB treatment protocol.
Design
Patients will undergo testing and evaluations as required by the appropriate NCI-SB treatment protocol.
详细描述
Background:
Potential research candidates undergo thorough screening including laboratory tests, scans, x-rays, and review of pathology slides to determine initial eligibility for National Cancer Institute Surgery Branch (NCI-SB) research protocols.
Objectives:
Permit evaluation of patients referred to the NCI-SB in order to identify individuals who will be suitable candidates for NCI-SB clinical research protocols.
To assess frequency of HLA type, gene specific mutations or expression of neo antigens in malignant tumors across the population of cancer patients undergoing screening for NCI-SB protocols.
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:
- •Age >= 18 years.
- •Patient suspected of having, or with biopsy proven, malignant disease.
- •Patient is able to understand and willing to sign a written informed consent document.
- •Patient is being evaluated for treatment on an NCI-SB protocols.
排除标准
- •Women of child-bearing potential who are pregnant or plan to become pregnant because of the potentially dangerous effects of some of the screening procedures (e.g., nuclear medicine or other imaging scans) on the fetus.
研究组 & 干预措施
A/Surgery Branch Protocol Candidates
Patients suspected of having, or with biopsy proven, malignant disease being evaluated for or treated on NCI Surgery Branch protocols
结局指标
主要结局
Frequency of HLA type, gene specific mutations, or expression of neoantigens in malignant tumors
时间窗: 25 years
Frequency of HLA type, gene specific mutations, or expression of neoantigens in tissue and blood samples
Results of screening tests
时间窗: 25 years
Results of screening tests for use on subsequent research protocol as baseline (e.g., pretreatment) values
Number of individuals suitable for NCI Surgery Branch clinical research protocols
时间窗: 25 Years
Total number of patients who enroll on NCI Surgery Branch clinical research protocols
次要结局
未报告次要终点