Foresight Diagnostics, a leader in ultra-sensitive minimal residual disease (MRD) detection technology, has announced the launch of the SHORTEN-ctDNA clinical trial at Columbia University. The study aims to assess the use of Foresight CLARITY™ MRD detection for real-time treatment optimization in patients with diffuse large B-cell lymphoma (DLBCL).
Foresight Diagnostics, a leader in ultra-sensitive minimal residual disease (MRD) detection technology, has launched the SHORTEN-ctDNA clinical trial at Columbia University. This study aims to explore whether early detection of circulating tumor DNA (ctDNA) can allow for personalized treatment in patients with diffuse large B-cell lymphoma (DLBCL), potentially reducing the number of chemotherapy cycles required while maintaining long-term survival.
Currently, the standard treatment for newly diagnosed DLBCL involves six cycles of rituximab combined with chemotherapy, regardless of how each patient responds. This “one-size-fits-all” approach can lead to patients receiving unnecessary treatment. The SHORTEN-ctDNA trial seeks to determine if patients who clear ctDNA early in their treatment can safely reduce their chemotherapy cycles without compromising long-term outcomes.
“Although PET scans are commonly used to monitor lymphoma treatment, their inconsistent results in detecting active disease limit our ability to make real-time treatment decisions,” said Dr. David Kurtz, Chief Medical Officer and Head of Research at Foresight Diagnostics. “Foresight CLARITY’s ability to detect residual disease could be a breakthrough, enabling us to adjust therapy based on a patient’s actual response rather than relying on less precise imaging techniques.”
The study will enroll approximately 32 newly diagnosed DLBCL patients. After completing three cycles of R-CHOP or pola-R-CHP chemotherapy, patients will undergo ctDNA testing. Those who remain MRD-positive will continue their treatment with rituximab plus chemotherapy for the remaining cycles. However, patients who achieve undetectable ctDNA levels (MRD-negative) will switch to rituximab alone for the final two cycles.
“Recent evidence shows that many patients achieve deep remissions earlier in their treatment than previously thought,” said Dr. Hua-Jay Cherng, Assistant Professor of Medicine at Columbia University and Principal Investigator of the study. “By using next-generation, ultra-sensitive ctDNA technology, SHORTEN-ctDNA aims to identify these early responders and personalize their treatment strategy. This could potentially shorten treatment duration, reduce toxicity, and allow patients to return to their normal lives sooner.”
Foresight Diagnostics is a privately held cancer diagnostics company with a CLIA-registered laboratory. Its liquid biopsy platform, Foresight CLARITY™, offers a novel assay that detects MRD with unparalleled sensitivity. This technology holds the potential to offer more personalized treatment approaches for patients with solid tumors and hematologic malignancies, benefiting both physicians and biopharmaceutical companies.