The trial will evaluate approaches to increase germline genetic testing among at-risk family members, as well as the impact of multigene panel testing on care for newly diagnosed patients. Leveraging its Invitae testing, Labcorp will serve as the exclusive genetic testing provider, supporting participating sites with its national scale and scientific expertise.
Inherited genetic variants contribute to approximately 10% of all colorectal cancer cases. Testing family members of individuals with an inherited cancer-associated variant, called cascade testing, is a well-established approach to cancer prevention—particularly for Lynch syndrome, the most common hereditary colorectal cancer syndrome. However, studies indicate that less than one third of at-risk relatives receive recommended genetic testing.
The trial will assess whether proactive outreach by healthcare providers, rather than relying on patients to communicate genetic risk to their relatives, can improve participation of first-degree relatives in cascade genetic testing. In parallel, the trial will assess the impact of multigene panel testing on care for patients newly diagnosed with colorectal cancer.
"Genetic testing is a critical tool for identifying inherited cancer risk and guiding care for patients and their families, but too often at-risk relatives are not getting tested," said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp. "By supporting this trial and serving as the exclusive genetic testing provider, Labcorp is helping generate real-world evidence on how healthcare providers can connect families to genetic testing and follow-up care."
The trial is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and led and conducted by the Alliance for Clinical Trials in Oncology. It includes participation from the NCI National Clinical Trials Network, which comprises academic medical centers, community oncology health systems and NCI-designated cancer centers. The study is expected to enroll patients and their relatives nationwide, including sites in Puerto Rico.
"By involving cancer care providers across our network, this study aims to evaluate a practical approach that can strengthen genetic risk identification for patients and their families," noted Frank A. Sinicrope, MD, from the Mayo Clinic and Heather Hampel, MS, CGC, from City of Hope, who are co-lead investigators for the trial. "The findings have the potential to help shape how genetic testing results are communicated to at-risk relatives in patients with colorectal cancer who have hereditary cancer syndromes nationwide."
This collaboration reflects Labcorp's continued commitment to advancing genetics-based approaches to improve outcomes for patients with cancer, while supporting high-impact clinical research in collaboration with leading research organizations.
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