Multi-Cancer Detection Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 500
- 试验地点
- 6
- 主要终点
- Financial impact of MCD testing
研究概览
简要总结
This study assesses the incorporation of Multi-Cancer Detection (MCD) testing, designed to detect many types of cancer, into clinical practice to understand both its use and effect in real world practice conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has Mayo Clinic medical record number
- •Has undergone (within last 6 months) or scheduled to undergo a multi-cancer detection test (MCD) as ordered by provider
- •Able to provide informed consent
- •≥ 21 years old
- •Ability to provide blood sample
排除标准
- •Individuals who have situations that would limit compliance with the study requirements
- •Institutionalized (i.e. Federal Medical Prison)
- •Known pregnancy (self-reported)
- •Currently undergoing active cancer treatment other than adjuvant hormone therapy
- •Invasive cancer diagnosis within the last 3 years
研究组 & 干预措施
Observational
Patients complete surveys and have their medical records reviewed on study. Patients may undergo blood or buccal swab and urine sample collection on study.
干预措施: Blood Sample (Procedure)
Observational
Patients complete surveys and have their medical records reviewed on study. Patients may undergo blood or buccal swab and urine sample collection on study.
干预措施: Surveys (Other)
结局指标
主要结局
Financial impact of MCD testing
时间窗: Up to 5 years
Assessed by types of diagnostic studies ordered as a result of positive MCD test results (e.g., to establish or rule out a cancer diagnosis).
Positive actionable MCD results
时间窗: Up to 5 years
Assessed by the number of participants who receive positive MCD results
Psychological Impact of MCD Testing
时间窗: Baseline (after receiving MCD results)
Assessed with the Multidimensional Impact of Cancer Risk Assessment (Adapted MICRA), which asks participants to evaluate their response to MCD test results over the past week. The MICRA consists of 20 items answered on a 4-point scale (Never, Rarely, Sometimes, Often). Higher scores generally indicate higher levels of distress or psychological impact.
Change in Patient Satisfaction with MCD Test
时间窗: Baseline; After receiving MCD results (up to 5 years)
Participants will complete a 3-question survey, "Satisfaction with the Multi-Cancer Detection Test." Items are answered on a 5-point scale (not at all, a little, somewhat, very, extremely).
次要结局
未报告次要终点