Approximately 100,000 patients with stage 1 to stage 3 solid tumors will be enrolled onto the trial across 25 sites, according to the manufacturer of the test aimed at detecting cancer recurrence.
Strata Oncology announced that the first patient has been enrolled onto its Strata Sentinel trial.
The aim of the study, according to a news release issued by the company, is to assess the ability of its investigational test product to detect the presence of a cancer recurrence in individuals with stage 1 to stage 3 solid tumors.
Moreover, the study sponsor hopes to evaluate if there’s a clinical benefit of treatment in patients with early-stage disease who either are or become positive for circulating tumor DNA after surgery or other treatments that are intended to cure patients.
Of note, a test that looks for circulating tumor DNA can identify if there is a presence of residual cancer left in a patient after a particular treatment.
“We are pleased to be a part of the Strata Sentinel trial,” Dr. Marc Matrana, director of the Precision Cancer Therapies Program and associate director of Clinical Cancer Research at Ochsner Cancer Institute in Jefferson, Louisiana, said in a news release. “Bringing the latest innovations in precision oncology to our patients is critical to our vision of changing and saving lives. We look forward to working with Strata Oncology to change the paradigm of care for patients with early-stage cancer.”
The first patient enrolled on the trial is being observed by clinicians at Ochsner.
The test, known as StrataMRD, is a personalized circulating tumor DNA assay used to detect the recurrence of a patient’s cancer and monitor if treatment has been effective. According to the manufacturer, if a test comes back positive for circulating tumor DNA, providers can use the tumor tissue sample to derive a comprehensive therapy selection profile.
The plan, the release noted, is to enroll approximately 100,000 patients across 25 sites. A blood sample is scheduled to be collected from participants every three months and if a recurrence is detected, the patient’s treatment team can then determine a potential treatment plan.
“In the future we’ll know very soon after initial treatment which early-stage cancer patients are or are not destined for recurrence,” Dan Rhodes, the co-founder and CEO of Strata Oncology, said in the release. “With that information, we can get patients who need their optimal precision therapy long before a full-on recurrence of metastatic disease, and we can spare those patients who really are cured from the toxicities and costs of unnecessary adjuvant treatment.”
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