Integrated Genomics and Patient-Derived Cancer Models
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Proteomic changes in both biopsies and resected tumors
研究概览
简要总结
This study characterizes deoxyribonucleic acid (DNA) and proteomic (protein) changes in both biopsies and tumors removed during surgery of patients who have been diagnosed with aggressive/metastatic (that has spread to other places in the body) cancer in order to identify possible diagnostic markers and potential drugs for treating aggressive tumor types. Proteomic analyses include looking at the proteome, or all the proteins expressed, or made by DNA at a specific moment in time. Studying samples of blood, buccal (cheek), and tissue in the laboratory from patients undergoing surgical resection or biopsy may help doctors learn more about the changes that occur in the proteome, DNA alterations, and identify molecular biomarkers for which therapeutic drugs may exist. Studying the DNA in tumor tissue and in blood may also help researchers see if the tumor has important differences.
详细描述
PRIMARY OBJECTIVES:
I. To understand the pathogenesis, molecular mechanisms, and disease processes of malignancies.
II. To examine the utility of integrated genomics for discovery of targets or pathways involved in tumor/malignancy progression of patients with malignancies.
III. To observe for any evidence of anti-tumor activity from treatment if selected based on integrated genomics.
IV. To create and offer opportunities for targeted individualized therapy based on the outcome of integrated genomics and micro-cancer modeling.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients (or the legally authorized representative/guardian signing on behalf of the participant) must understand and provide written informed consent prior to initiation of any study-specific procedures
- •>= 18 years of age
- •Patients must have a diagnosis of confirmed malignancy
- •Patient is a good medical candidate for a standard of care biopsy or surgical procedure to obtain tissue or has archival tissue available for analysis
排除标准
- •Uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
- •Inaccessible tumor for biopsy or patient does not have tumor tissue available for research use
- •Biopsy must not be considered to be more than minimal risk to the patient. Contraindications to percutaneous biopsy:
- •Significant coagulopathy that cannot be adequately corrected
- •Severely compromised cardiopulmonary function or hemodynamic instability
- •Lack of a safe pathway to the lesion
- •Inability of the patient to cooperate with, or to be positioned for, the procedure
结局指标
主要结局
Proteomic changes in both biopsies and resected tumors
时间窗: Through study completion; up to five years
identify molecular targets for which therapeutic drugs may exist
Deoxyribonucleic acid (DNA) alterations
时间窗: Through study completion; up to five years
identify molecular targets for which therapeutic drugs may exist
次要结局
未报告次要终点