TRACK Study Seeks to Develop Precision Medicine Approaches for Rare Cancers

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Tumor profiling assays of Foundation Medicine and Caris Life Sciences will identify abnormalities qualifying a patient for personalized cancer treatment through NCI-MATCH. [Royalty Stock Photo/Shutterstock]
[Royalty Stock Photo/Shutterstock]

A new study sponsored by the non-profit TargetCancer Foundation (TCF) will leverage remote consent to recruit 400 people with rare forms of cancer with an eye toward providing these patients with effective precision treatments delivered by their own community-based physicians.

Dubbed the TRACK (Target Rare Cancer Knowledge) Study, study sponsor TCF is collaborating with rare cancer experts and will leverage the FoundationOne cancer tests, both for tissue and liquid biopsies, from molecular information company Foundation Medicine. Researchers for TRACK include Razelle Kurzrock, M.D., of the University of California San Diego (UCSD) and Vivek Subbiah, M.D. of the University of Texas MD Anderson Cancer Center (MD Anderson), who will serve as co-principal investigators. The research team also includes James Cleary, M.D., Ph.D., from Dana-Farber Cancer Institute, and Roman Groisberg, M.D., at the Rutgers Cancer Institute of New Jersey.

“The establishment of TRACK is a significant milestone for TargetCancer Foundation as we seek to help patients with often-overlooked rare cancers identify an effective treatment path,” says Jim Palma, executive director of TCF in a press release. “In partnership with the study’s investigators and Foundation Medicine, we will drive scientific understanding of traditionally understudied rare cancers while directly enabling patients and their physicians to make better-informed, individualized targeted therapy choices.”

TRACK will recruit 400 people diagnosed with any rare cancer, which is defined as incidence of six per 100,000 people, per year, in the U.S. The study will focus on cholangiocarcinoma and cancer of unknown primary due to the promise of precision approaches in these subsets. One enrolled, patients will receive genomic profiling of their cancer from Foundation Medicine via their solid tissue and liquid biopsy test FoundationOne to establish a baseline and then will receive additional testing over a one- to two-year period to track their disease.

“Foundation Medicine is dedicated to advancing the field of precision medicine through innovative collaborations,” says Brian Alexander, M.D., CMO, Foundation Medicine in a statement. “We are proud to partner with TargetCancer Foundation and Drs. Kurzrock, Subbiah, Cleary, and Groisberg to create an innovative research framework that not only provides doctors and patients with more accessible options, but also supports decision-making and learns from their journey.”

UCSD and MD Anderson Cancer will serve as enrolling sites, but patients also will have the option to enroll with TCF, without a requirement to travel to an enrolling site. This study feature will allow full participation from geographic areas that are often not served by clinical studies. A virtual molecular tumor board (VMTB) comprised of field leading oncologists, pathologists, surgeons and other experts will recommend treatment options, directed by the genomic information of each individual patient on study.

The resultant treatments and participant responses will be prospectively tracked for at least one year, linking molecularly-informed treatments to specific participant outcomes. Beyond potentially informing patient treatments, the data produced through TRACK will also contribute to the field’s understanding of genomics in rare cancers, meeting a critical need where such knowledge is otherwise lacking.

“With the introduction of the TRACK study, we can now offer rare cancer patients as well as oncology investigators a detailed analysis of critical genomic information that holds the promise of a targeted treatment protocol for each patient,” says Kurzrock. “While unprecedented advances throughout the field continue, lack of data and insights sometimes stymie progress for treating rare cancers. With TRACK we have the opportunity to advance rare cancer research and treatment through this exciting new partnership with TargetCancer Foundation and Foundation Medicine.”

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