Clinical Sequencing of Cancer and Tissue Repository: ClinOmics
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Identify incidental and secondary findings in germline DNA and actionable somatic mutations for reporting clinical results from a CLIA-certified lab into CRIS medical records.
研究概览
简要总结
Background:
Saliva, blood, tissue, and cancer contain DNA. DNA makes the "instruction book" for the cells in the body. Cancer is caused by changes in DNA that affect cell function. Researchers want to test DNA of people with tumors. They want to look for genetic changes in tumors that could be targets for treatment. Because DNA can change as cancer changes, more testing may be done at different times.
Objectives:
To find the DNA changes in cancer that may help guide treatment. To collect samples and data to be used in future studies.
Eligibility:
People any age with cancer or a pre-cancerous tumor
Design:
- Participants will be screened with a medical history, physical exam, and blood tests. Participants will give a sample of their tumor. This is usually from a previous procedure. Participants will give a saliva or blood sample. They cannot eat, drink, smoke, or chew gum for 30 minutes before giving saliva. They will spit about 1 teaspoon of saliva into a tube.
- Some participants may have a punch biopsy instead. A small instrument will take a small piece of skin.
- Researchers will collect data from participants medical records.
- Participants will answer questions about their family health history. They will also answer questions about their views on the study, including possible unexpected results.
- Extra blood or tissue samples may be taken at other times during the participants' treatment. All samples will be saved in secure ClinOmics freezers to be used in future studies.
- Participants will be told by their doctors if any test results affect their health or their cancer treatment.
详细描述
Background:
- Laboratory-based investigations have contributed to an improved understanding of the biology of cancer and to the development of new therapies for malignancies.
- Omics investigation may identify novel drivers in the germline or tumor for high risk, relapsed, refractory or rare cancers.
- Omics investigation may identify germline or somatic alterations that are medically actionable and or can enable precision therapy.
Objectives - Primary Objective:
-Identify incidental and secondary findings in germline DNA and actionable somatic mutations for reporting clinical results from a CLIA-certified lab into CRIS medical records.
Eligibility - Adult or Pediatric patients of any age with one of the following:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Identify incidental and secondary findings in germline DNA and actionable somatic mutations for reporting clinical results from a CLIA-certified lab into CRIS medical records.
时间窗: ongoing
Sample analysis.
次要结局
- Cryopreservation of viable tumor tissue for future study(ongoing)
- Creation of an OncoGenomics oversight committee(ongoing)
- Assessment of effects of the informed consent process(ongoing)
- Create a tissue repository(ongoing)
- Extraction and storage of circulating tumor DNA(ongoing)
- Establishment of EBV transformed cell lines for research(ongoing)
- Molecular, genomic, epigenetic, transcriptomic, proteomic, metabolomics and other "omics" profiling on tumors, malignancies and normal tissues(ongoing)
- Establishing Patient-derived models(ongoing)