GRAIL Galleri Test for Cancer
(DISCOVERY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new blood test called the GRAIL Galleri MCED test to determine its effectiveness in early cancer detection. It targets individuals showing signs or symptoms that might suggest cancer. Participants will undergo a blood test and complete questionnaires. If the test suggests cancer, further checks like scans or biopsies may be necessary. This trial suits those who haven't received cancer treatment in the last three years and are not currently undergoing treatment, except for certain hormone therapies. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to earlier cancer detection.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on hormone therapy for breast or prostate cancer, you can continue with it while participating.
What prior data suggests that the GRAIL Galleri MCED test is safe for cancer screening?
Research has shown that the GRAIL Galleri MCED test is generally easy for people to handle. It has a low false positive rate of just 0.4%, meaning it rarely indicates cancer when none is present. This reduces the likelihood of unnecessary follow-up tests like X-rays or scans.
Although the Galleri test has not yet received FDA approval, it is conducted in a regulated lab, ensuring accurate and safe results. Studies have demonstrated that it can detect signs of cancer in the blood, aiding in early cancer detection, even before symptoms appear.
Overall, the test appears safe for individuals. However, as with any medical test, discussing any concerns with a healthcare provider is important.12345Why are researchers excited about this trial?
The GRAIL Galleri MCED test is unique because it offers a non-invasive way to detect multiple types of cancer early through a simple blood draw. Unlike traditional methods, which often rely on noticeable symptoms or specific screenings like mammograms or colonoscopies, this test can potentially identify cancer signals in individuals who are asymptomatic. Researchers are excited because it could revolutionize early detection, leading to timely interventions and improved outcomes by identifying cancer before it progresses to more advanced stages.
What evidence suggests that the GRAIL Galleri MCED test is effective for cancer detection?
Research has shown that the GRAIL Galleri MCED test, which participants in this trial will receive, is promising for early cancer detection. In one study, the test found a cancer signal in 0.93% of participants, and 133 of them were diagnosed with cancer. Another study revealed that when a cancer signal was detected, 258 out of 459 participants actually had invasive cancer. The test can identify over 50 types of cancer, including some of the most dangerous ones, at early stages. Its ability to correctly find cancer (sensitivity) ranges from 50% to 95%, and its ability to correctly rule out cancer (specificity) is between 89% and 99%. These findings suggest the test could greatly enhance early cancer detection when used with other screenings.23567
Who Is on the Research Team?
Elizabeth O'Donnell, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for individuals who are interested in cancer screening. Specific eligibility criteria have not been provided, so it's best to contact the study organizers for detailed information on who can participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline visit with blood draw and questionnaires
Diagnostic Work-up
For positive results, diagnostic work-up could include clinic visits, biopsy, surgery, imaging assessments such as ultrasound, CT scans, or MRI scans
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GRAIL Galleri MCED test
Trial Overview
The DISCOVER Study is testing the GRAIL Galleri MCED test, a blood test that aims to detect multiple types of cancer early when treatment may be more effective.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Enrolled participants will complete: * Baseline visit with blood draw and questionnaires * Return of test results: * 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 standard, diagnostic work-up is positive or negative for cancer, follow up will be at the discretion of the principal investigator. * For a negative MCED blood test with standard, diagnostic work-up that is negative, follow-up will be at the discretion of the principal investigator. * Online post-test questionnaire * Online post-diagnostic questionnaire * Follow up will be up to 24 months
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Citations
GRAIL PATHFINDER 2 Results Show Galleri® Multi ...
The Galleri test detected a cancer signal in 216 participants (cancer signal detection rate of 0.93%), and of those, cancer was diagnosed in 133 ...
Real-world data and clinical experience from over ...
Providers reported clinical outcome for 459 of 1011 individuals with cancer signal detected MCED tests. Of these, 258 had an invasive cancer ...
Patient Reported Outcomes for GRAIL's Galleri® Multi ...
The patient-reported outcome findings from the PATHFINDER study suggest MCED testing is associated with a high level of satisfaction.
Multi-cancer early detection
* Galleri can detect 50+ cancer types, with high sensitivity for many of the deadliest cancers in early stages**, and it predicts the Cancer Signal Origin (CSO) ...
the potential of multi-cancer early detection (MCED ... - PMC
Large trials have reported promising results, achieving 50–95% sensitivity and 89–99% specificity for multiple cancer types. However, challenges ...
Galleri® multi-cancer early detection test
Galleri has a false positive rate of just 0.4%— the lowest of any available MCED test ** — helping to minimize unnecessary procedures and exposure to radiation.
Blood Test for Cancer Screening | Galleri®
The Galleri test can be taken annually as a simple blood test and screens for a “fingerprint” of many of the deadliest cancers before they become symptomatic.
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