Whole Body MRI and Liquid Biopsy for Early Cancer Detection
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Acceptability of germline testing, liquid biopsy and whole body magnetic resonance imaging (WBM)
研究概览
简要总结
This study evaluates patient acceptability of whole body magnetic resonance imaging (WBM) and liquid biopsies (LB) in detecting early stage cancer in patients with a strong family history of cancer. Collecting family history and testing for genes passed on from parent to child (germline testing) can be used to predict the likelihood of a patient developing cancer. Currently, detection of early cancers focuses on screening specific organ systems such as breast and colon cancer. Magnetic resonance imaging (MRI) uses a large magnet and radio waves to look at organs and structures inside the body. Health care professionals use MRI scans to diagnose a variety of conditions, from torn ligaments to cancer. Liquid biopsy is test that analyzes blood samples to determine if cancer cells are present. This study may help researchers determine the feasibility of WBM and liquid biopsies to detect early stage cancer in patients that have a strong family history of cancer.
详细描述
PRIMARY OBJECTIVE:
I. To assess the acceptability of the approach of LB and WBM.
SECONDARY OBJECTIVES:
I. Determine the prevalence of WBM findings requiring additional imaging or invasive testing.
II. Determine the effect of germline testing, LB, and WBM on psychological distress and health-related quality of life (HR-QOL) at 6 months after testing compared with baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >= 50 years, or age within 10 years of first degree relative with cancer at age of diagnosis (as long as age is >= 18)
- •Have a strong family history of cancer ( >= 2 first-degree relatives with cancer, one first and second degree relative with cancer in one lineage (side of family), or at least three first or second degree relatives with cancer in one lineage (side of the family). Non-melanoma skin cancer excluded from family history eligibility
- •Have a family history of early-onset cancer (age >40) in at least one first-degree relative
- •Willing to have 50 mL of blood (approximately 3.5 tablespoons) drawn (40 ml if germline testing already performed)
- •Able to undergo MRI (no implants, metal, or claustrophobia that would preclude MRI)
- •Any cancer diagnosis within past 5 years, excluding non-melanoma skin cancer
- •Positron emission tomography/computed tomography (PET/CT) or other whole body imaging modality (including combination of CT chest and abdomen) within 3 years
- •No signs/symptoms of possible cancer (e.g. hemoptysis, breast mass, blood per rectum, unexplained weight loss)
- •Willing to undergo standard of care genetic counseling and germline testing, or has already undergone genetic counseling and germline testing
- •Documented informed consent of the participant
排除标准
- •Unable to provide informed consent
- •Contraindications to MRI (implants, metal, or claustrophobia that would preclude MRI)
研究组 & 干预措施
Whole Body MRI and Liquid Biopsy
Patients undergo WBM without contrast and blood sample collection for liquid biopsy
干预措施: Genetic Testing for Cancer Risk (Genetic)
Whole Body MRI and Liquid Biopsy
Patients undergo WBM without contrast and blood sample collection for liquid biopsy
干预措施: Biospecimen Collection (Procedure)
Whole Body MRI and Liquid Biopsy
Patients undergo WBM without contrast and blood sample collection for liquid biopsy
干预措施: Liquid Biopsy (Procedure)
Whole Body MRI and Liquid Biopsy
Patients undergo WBM without contrast and blood sample collection for liquid biopsy
干预措施: Magnetic Resonance Imaging of the Whole Body without Contrast (Procedure)
Whole Body MRI and Liquid Biopsy
Patients undergo WBM without contrast and blood sample collection for liquid biopsy
干预措施: Survey Administration (Other)
结局指标
主要结局
Acceptability of germline testing, liquid biopsy and whole body magnetic resonance imaging (WBM)
时间窗: Up to 6 months after WBM
Acceptability, as measured by the survey question "How satisfied are you with the research study overall?" and is defined as a score of 4 ("moderately acceptable) or 5 ("highly acceptable").
次要结局
- Psychological distress (WBM)B(Up to 6 months after WBM)
- Psychological distress (Germline testing)A(Up to 6 months after WBM)
- Psychological distress (WBM)A(Up to 6 months after WBM)
- Prevalence of WBM findings requiring additional imaging or invasive testing(Up to 6 months after WBM)
- Psychological distress (Germline testing)B(Up to 6 months after WBM)
- Psychological distress (Liquid Biopsy)B(Up to 6 months after WBM)
- Psychological distress (Liquid Biopsy)A(Up to 6 months after WBM)
- Health Related Quality of Life (HRQOL/Germline)(Up to 6 months after WBM)
- Health Related Quality of Life (HRQOL/LB)(Up to 6 months after WBM)
- Health Related Quality of Life (HRQOL/WBM)(Up to 6 months after WBM)