Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Military Population: The Sentinel Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Positive predictive value at 12 Months
研究概览
简要总结
The purpose of this research study is to evaluate the possible benefits of an investigational, but commercially available Galleri multi-cancer early detection (MCED) blood test which is designed to detect many types of cancer early in veterans who have served in the military in active duty.
The name of the screening blood test being studied is:
-GRAIL Galleri MCED test
详细描述
This research study aims to assess the performance of the Galleri multi-cancer early detection (MCED) screening test in a military population and to compare the number and types of cancers diagnosed using MCED testing versus standard of care. This research study will give doctors and participants results of Galleri® blood tests which is designed to detect many types of cancer.
The research study procedures including screening for eligibility, blood draws, questionnaires, and clinic visits.
Participation in this research study is expected to last for up to 1 year.
It is expected that about 1,500 people will take part in this research study.
The Department of Defense (DoD) is funding this study.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Active-duty or National Guard/Reserves military service for eight or more years
- •Received care at a VA facility within past 5 years
- •Able to sign informed consent
- •Willingness to travel to Dana-Farber Cancer Institute in Boston, MA, for diagnostic testing if screening test indicates possible malignancy
排除标准
- •Individuals diagnosed with invasive malignancy within 3 years of enrollment (non- melanoma skin cancer is acceptable)
- •Individuals with evidence of symptomatic or active cancer requiring therapeutic intervention at the time of participation (hormone therapy for breast/prostate cancer is acceptable)
- •Individuals in the process of being evaluated for a clinical suspicion of cancer
结局指标
主要结局
Positive predictive value at 12 Months
时间窗: At 12 months
Positive predictive value is defined as the proportion of participants with cancer diagnosis out of all participants with "signal detected" on GRAIL Galleri MCED test results.
Specificity Rate at 12 Months
时间窗: At 12 months
Specificity is defined as the proportion of participants with "signal not detected" results out of all participants with no cancer diagnosis on GRAIL Galleri MCED test results.
Negative predictive value at 12 Months
时间窗: At 12 months
Negative predictive value is defined as the proportion of participants with no cancer diagnosis out of all participants with "signal not detected" on GRAIL Galleri MCED test results.
Yield Rate at 12 Months
时间窗: At 12 months
Yield rate is defined as the proportion of participants with "signal detected" out of all participants tested on GRAIL Galleri MCED test.
Number of Participants Needed to Screen at 12 months
时间窗: At 12 months
Number Needed to Screen (NNS) is defined as the number of participants screened to detect a diagnosis of invasive cancer on the GRAIL Galleri MCED test.
次要结局
- Change in PROMIS Anxiety Short Form Score(Baseline to 12 months)
- Change in PROMIS Global Health Score(Baseline to 12 months)
- Stage of Invasive Cancer Diagnosis Comparison(Up to 12 months)
- Cancer Detection Rate Comparison(Up to 12 months)
研究者
Elizabeth ODonnell
Principal Investigator
Dana-Farber Cancer Institute