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Trial Title:
Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Military Population: The Sentinel Study
NCT ID:
NCT06523868
Condition:
Cancer Diagnosis
Conditions: Official terms:
Disease
Conditions: Keywords:
Cancer Diagnosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
GRAIL Galleri
Description:
A multi-cancer early detection (MCED) blood test.
Arm group label:
Galleri MCED Test
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
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Active-duty military service for eight 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
- Individuals with known hematologic precursor disease (e.g., clonal hematopoiesis of
indeterminate potential (CHIP), monoclonal gammopathy of undetermined significance
(MGUS), which may result in a cancer signal detected on the MCED test)
Gender:
All
Minimum age:
45 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Start date:
January 2025
Completion date:
September 30, 2028
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Collaborator:
Agency:
United States Department of Defense
Agency class:
U.S. Fed
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06523868
