Clinical trial NCT06523868: Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Military Population: The Sentinel Study
Official title: Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Military Population: The Sentinel Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Diagnosis
Keywords: Cancer Diagnosis
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-07-26
Enrollment: 1500
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Active-duty or National Guard/Reserves 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

Primary outcomes:
measure: Positive predictive value at 12 Months
timeFrame: At 12 months
measure: Negative predictive value at 12 Months
timeFrame: At 12 months
measure: Specificity Rate at 12 Months
timeFrame: At 12 months
measure: Yield Rate at 12 Months
timeFrame: At 12 months
measure: Number of Participants Needed to Screen at 12 months
timeFrame: At 12 months
Secondary outcomes:
measure: Cancer Detection Rate Comparison
timeFrame: Up to 12 months
measure: Stage of Invasive Cancer Diagnosis Comparison
timeFrame: Up to 12 months
measure: Change in PROMIS Anxiety Short Form Score
timeFrame: Baseline to 12 months
measure: Change in PROMIS Global Health Score
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Elizabeth ODonnell, MD
role: PRINCIPAL_INVESTIGATOR
References: