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Cancer Vaccine

Early Detection Blood 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

Age ≥ 45

Be older than 18 years old

Must not have

Individuals diagnosed with invasive malignancy within 3 years of enrollment (non-melanoma skin cancer is acceptable)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a new blood test called GRAIL Galleri MCED can detect various types of cancer early in military veterans.

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

Select...

I am 45 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I was diagnosed with cancer other than non-melanoma skin cancer in the last 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met