Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Military Population: The Sentinel Study
NCT Number: NCT06523868
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer Diagnosis
Interventions: OTHER: GRAIL Galleri
Sponsor: Dana-Farber Cancer Institute
Collaborators: United States Department of Defense
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1500
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2025-01
Completion Date: 2028-09-30
Locations: Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States

Summary:
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

Primary Outcome Measures: Positive predictive value 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., At 12 months|Negative predictive value 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., At 12 months|Specificity Rate 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., At 12 months|Yield Rate 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., At 12 months|Number of Participants Needed to Screen 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., At 12 months
Secondary Outcome Measures: Cancer Detection Rate Comparison, Descriptive statistics will be used to summarize the number and types of cancers diagnosed by GRAIL Galleri MCED testing compared to Standard of Care (SOC) in matched population from the VA (separate IRB protocol)., Up to 12 months|Stage of Invasive Cancer Diagnosis Comparison, Descriptive statistics will be used to summarize the stages of invasive cancer that are diagnosed by GRAIL Galleri MCED testing assessed by medical record review compared to Standard of Care (SOC) in matched population from the VA (separate IRB protocol)., Up to 12 months|Change in PROMIS Anxiety Short Form Score, Changes in anxiety following the GRAIL Galleri MCED test result and assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Emotional Distress Anxiety - Short Form 6a, which is a 6 item survey that is rated on a 5-point Likert scale with answers ranging from "Never" to "Always". The range of scoring is from 6 to 30 with higher scores indicating greater severity of anxiety., Baseline to 12 months|Change in PROMIS Global Health Score, Changes in health-related quality of life following the GRAIL Galleri MCED test result and assessed by PROMIS Scale v1.2 - Global Health, a 10 item survey that is rated on a 5-point Likert scale with answers ranging from "Excellent/Completely/Never/None" to "Poor/Not at all/Always/Very Severe" and includes a pain average question rated on a scale of 0 "No Pain" to 10 "Worst Pain Imaginable." The range of scoring is from 9 to 45 with higher scores indicating higher quality of life., Baseline to 12 months