Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Military Population: The Sentinel Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GRAIL Galleri.
- Who it may be relevant to
- Registry conditions: Cancer Diagnosis. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Detailed description
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.
Interventions
- Other GRAIL Galleri
A multi-cancer early detection (MCED) blood test.
Primary outcome measures
- Positive predictive value at 12 Months [Time frame: At 12 months]
- Negative predictive value at 12 Months [Time frame: At 12 months]
- Specificity Rate at 12 Months [Time frame: At 12 months]
- Yield Rate at 12 Months [Time frame: At 12 months]
- Number of Participants Needed to Screen at 12 months [Time frame: At 12 months]
Secondary outcome measures (4)
- Cancer Detection Rate Comparison [Time frame: Up to 12 months]
- Stage of Invasive Cancer Diagnosis Comparison [Time frame: Up to 12 months]
- Change in PROMIS Anxiety Short Form Score [Time frame: Baseline to 12 months]
- Change in PROMIS Global Health Score [Time frame: Baseline to 12 months]
Eligibility criteria
Inclusion criteria
- Active-duty or National Guard/Reserves military service for four or more years
- Age ≥ 45
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Dana-Farber Cancer Institute — Boston
Identifiers
NCT: NCT06523868 · 24-277