Galleri Blood Test for Ovarian Cancer

(OC-LEAD Trial)

This trial examines how a blood test called Galleri can help detect ovarian cancer early in individuals at high risk. The test targets those with BRCA1 or BRCA2 gene changes, which increase the risk of ovarian cancer. The trial evaluates the test's usability, acceptability, and effectiveness in detecting cancer or early warning signs. Participants will take the test, complete questionnaires, and possibly participate in an interview. Those with a diagnosis related to their BRCA1/2 genes or a recent STIC lesion (an early cancer sign) might be suitable candidates.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to earlier detection of ovarian cancer.

Research has shown that the Galleri multi-cancer early detection blood test is generally safe. In studies with over 25,000 participants, the test did not cause major health issues for most people. The most common side effects were minor, such as bruising at the blood draw site, dizziness, and anxiety. These effects are typical for blood tests and usually not serious.

Researchers are excited about the Galleri Multi-Cancer Early Detection (MCED) Blood Test because it represents a non-invasive method for detecting ovarian cancer. Unlike traditional options like surgery or imaging, this blood test can potentially identify cancer early by analyzing DNA fragments in the blood, which might reflect tumor presence. For individuals with BRCA1/2 variants or prior serous tubal intraepithelial carcinoma (STIC), early detection is crucial, and this test offers a way to monitor these high-risk groups effectively and continuously. The hope is that by catching cancer earlier, outcomes can improve significantly compared to current standards.

Research has shown that the Galleri blood test is designed to detect many types of cancer by identifying signs in the blood. Early results suggest this test can find cancer signals before symptoms appear. In this trial, participants in Cohort A, who have pathogenic or likely pathogenic BRCA1/2 variants, will receive the Galleri test before undergoing planned risk-reducing gynecologic surgery. Participants in Cohort B, with a prior diagnosis of serous tubal intraepithelial carcinoma (STIC), will receive the test at baseline and annually for up to 10 years. Although data specifically for ovarian cancer is limited, the test appears promising because it can screen for various cancers. As more information becomes available, the hope is that the Galleri test will become a reliable tool for early cancer detection, especially for those at high risk.⁶⁷⁸⁹¹⁰