Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12,000
- 试验地点
- 1
- 主要终点
- Frequency of mutations and co-mutations
研究概览
简要总结
This study performs standardized testing of tumor tissue samples to learn which genes are mutated (have changed) in order to provide personalized cancer therapy options to cancer patients at MD Anderson. This may help doctors use testing information on tumors to identify clinical trials that may be most relevant to patients. Researchers may also use the information learned from this study to develop a database of the different kinds of mutations in cancer-related genes.
详细描述
PRIMARY OBJECTIVES:
I. To perform molecular analysis for patients at MD Anderson to assist in personalized cancer therapy.
II. To determine the frequency of mutations, co-mutations and, other alterations including germline polymorphism and deleterious mutations (germline genetic factors), in cancer-related genes within different tumor types, and to determine patient preference for return of results.
III. To establish a database of somatic mutations, copy number alterations, gene fusion/translocation information and other biomarker alterations and clinical characteristics that can be used to select patients that may be eligible for new targeted therapy trials.
SECONDARY OBJECTIVES:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically, radiographic, or cytologically documented cancer, suspected glioma, sarcoma, melanoma or hematologic cancer. Patients with benign tumors may also be consented at the discretion of the attending physician if molecular profiling is felt to have potential clinical implications.
- •Patients must have the ability to understand and the willingness to sign a written informed consent document
- •Patients may be consented without confirming the amount and quality of archival diagnostic or residual tissue available. However, research testing will only be performed on patients who have sufficient archived diagnostic tissue or residual tissue banked in one of the authorized tissue banks at MD Anderson available to proceed with testing. The extent of testing may be modified based on amount of tissue available. If any new tissue acquisition including a biopsy and/or surgical resection etc. is being ordered for clinical care or another research study, or an operation is being performed testing can be ordered on that sample
- •Circulating cell-free deoxyribonucleic acid (cfDNA) Cohort: Circulating cell-free DNA next generation sequencing (NGS) testing will be performed with the Clinical Laboratory Improvement Act (CLIA)-certified Guardant360 panel (or equivalent) for select patients. This particular cohort of research collaboration will be supported by Guardant Health, Inc. at no charge to MD Anderson. Patients who are being considered for enrollment into clinical trials in the next 2 lines of therapy may be enrolled. Selected patients may have cfDNA, circulating RNA /exosome/circulating tumor cell testing approaches performed on alternate platforms (eg Foundation ACT)
排除标准
- 未提供
研究组 & 干预措施
Ancillary-correlative (biospecimen collection, chart review)
Patients' previously collected tissue samples are analyzed. Patients may also undergo collection of blood, saliva or buccal samples for analysis. Patients' medical records are reviewed.
干预措施: Biospecimen Collection (Procedure)
Ancillary-correlative (biospecimen collection, chart review)
Patients' previously collected tissue samples are analyzed. Patients may also undergo collection of blood, saliva or buccal samples for analysis. Patients' medical records are reviewed.
干预措施: Genetic Testing (Other)
Ancillary-correlative (biospecimen collection, chart review)
Patients' previously collected tissue samples are analyzed. Patients may also undergo collection of blood, saliva or buccal samples for analysis. Patients' medical records are reviewed.
干预措施: Medical Chart Review (Other)
结局指标
主要结局
Frequency of mutations and co-mutations
时间窗: 20 years
Will be assessed with descriptive statistics along with 95% Wilson score confidence intervals.
Distributions of mutations (including on gene expressions)
时间窗: 20 years
Distributions of mutations (including on gene expressions) between different tumor types and levels of clinical-pathological factors will be compared using the chi-squared test or Fisher's exact test, as appropriate for categorical variables
Database of somatic mutations and clinical characteristics
时间窗: 20 years
Collection and storage of tumor tissue specimens, blood and/or saliva samples of patients with cancer for somatic mutation analysis for assessing patients that may be eligible for new targeted therapy trials.
次要结局
未报告次要终点