UCSF Biobank for Studying Hereditary Cancers and Tumor-Associated Mutations
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 50,000
- 试验地点
- 2
- 主要终点
- Develop participant-derived tumor models of hereditary cancers
研究概览
简要总结
This is a non-therapeutic clinical research biorepository protocol designed to obtain, store, and clinically annotate biospecimens from participants with hereditary cancers. Those biospecimens will be used to generate participant-derived tumor models that will serve as a resource to better understand hereditary cancers and develop new efficient therapies.
详细描述
Primary Objective:
- To generate a repository of participant-derived tumor models* and specimens** - annotated with demographic, clinical, and pathologic data - from adults with solid tumor malignancies with germline or somatic tumor-associated mutations and/or a personal or family history of cancer.
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Participant-derived models may include (but are not limited to) xenografts (PDX), organoids (PDO), and cell lines (PDCLs).
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Specimens may include tissue, ascites and pleural fluid, and blood.
Exploratory Objectives
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •For participants undergoing collection of tissue, ascites, and/or pleural effusions:
- •Ability to understand and willingness to voluntarily sign a written informed consent document prior to any study-related assessments or procedures are conducted.
- •Individuals 18 years of age or older on the day of signing informed consent.
- •Individuals with solid tumor malignancy with germline or somatic cancer-associated mutations and/or Individuals with a family history or personal history of cancer.
- •Must be planning to undergo one of the following procedures as part of their routine care (or as a research procedure under a UCSF-sponsored IIT protocol):
- •Surgical resection
- •Biopsy (open, incisional, excisional, punch, core needle, and/or fine needle aspiration (FNA) are all permitted)
- •Paracentesis
- •Thoracentesis
- •For participants undergoing blood banking:
- •Ability to understand and willingness to voluntarily sign a written informed consent document prior to any study-related assessments or procedures are conducted.
- •Individuals 18 years of age or older on the day of signing informed consent.
- •Individuals with a family history or personal history of cancer.
- •Must be planning to undergo a blood draw as part of their routine care (or as a research procedure under a University of California, San Francisco (UCSF) -sponsored investigator-initiated trial (IIT) protocol); or willing to undergo an additional blood draw outside of their routine care.
排除标准
- •1. Known history of HIV, Hepatitis B, or Hepatitis C (as documented in the medical record) or other infectious disease that in the judgment of the investigator could pose a risk to research personnel or mice, or negatively impact Patient derived xenografts (PDX) tumor engraftment.
研究组 & 干预措施
Adults with solid tumor malignancies
Participants' biospecimen samples (Tissue, Excess fluid (i.e., ascites, pleural effusions, and Blood) will be obtained during non-study, routine medical visits whenever possible, to minimize participant risk. Blood samples will be collected up to 5 times from consenting participants.
干预措施: Excess fluid Sample (Procedure)
Adults with solid tumor malignancies
Participants' biospecimen samples (Tissue, Excess fluid (i.e., ascites, pleural effusions, and Blood) will be obtained during non-study, routine medical visits whenever possible, to minimize participant risk. Blood samples will be collected up to 5 times from consenting participants.
干预措施: Blood Sample (Procedure)
Adults with solid tumor malignancies
Participants' biospecimen samples (Tissue, Excess fluid (i.e., ascites, pleural effusions, and Blood) will be obtained during non-study, routine medical visits whenever possible, to minimize participant risk. Blood samples will be collected up to 5 times from consenting participants.
干预措施: Tissue Sample (Procedure)
Adults with solid tumor malignancies
Participants' biospecimen samples (Tissue, Excess fluid (i.e., ascites, pleural effusions, and Blood) will be obtained during non-study, routine medical visits whenever possible, to minimize participant risk. Blood samples will be collected up to 5 times from consenting participants.
干预措施: Medical Chart Review (Other)
结局指标
主要结局
Develop participant-derived tumor models of hereditary cancers
时间窗: Up to 10 years
Participant-derived models may include (but are not limited to) xenografts (PDX), organoids (PDO), and cell lines (PDCLs). These models recapitulate the biology and tissue context of the original tumors from which they are derived and can be used to study effective therapeutic strategies.
次要结局
未报告次要终点