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Cancer Vaccine

Galleri MCED Test for Cancer

N/A
Waitlist Available
Led By Elizabeth ODonnell, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Active-duty military service for eight or more years
* Age ≥ 45
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months
Awards & highlights

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

Who is the study for?
This trial is for veterans who have served in active military duty and are interested in early cancer detection. Specific eligibility criteria are not provided, but typically participants would need to be at a higher risk of developing cancer.
What is being tested?
The study is testing the GRAIL Galleri multi-cancer early detection (MCED) blood test, which aims to identify various types of cancers before symptoms appear by analyzing DNA in the participant's blood.
What are the potential side effects?
As this intervention involves a non-invasive blood test, side effects are minimal and may include discomfort or bruising at the needle site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Negative predictive value at 12 Months
Number of Participants Needed to Screen at 12 months
Positive predictive value at 12 Months
+2 more
Secondary study objectives
Cancer Detection Rate Comparison
Change in PROMIS Anxiety Short Form Score
Change in PROMIS Global Health Score
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Galleri MCED TestExperimental Treatment1 Intervention
Enrolled participants will complete: * Baseline visit with blood draw and questionnaires * Return of study test result * Online post-test questionnaire * For a positive result, diagnostic work-up could include clinic visits, biopsy, surgery, imaging assessments such as ultrasound, Computed Tomography (CT) scans, or Magnetic Resonance Imaging (MRI) scans. If no cancer is found upon work up, a repeat MCED test may be ordered at the discretion of the principle investigator for up to 1 year from the initial MCED blood test. * Follow-up for a negative MCED blood test could include a repeat test ordered by the principle investigator for up to 1 year from the initial MCED test or a survey or phone call by study staff approximately 1 year after the initial MCED blood test. * Online post-diagnostic questionnaire.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,090 Previous Clinical Trials
342,222 Total Patients Enrolled
United States Department of DefenseFED
882 Previous Clinical Trials
330,433 Total Patients Enrolled
Elizabeth ODonnell, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
1,000 Total Patients Enrolled
~1000 spots leftby Sep 2027
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