A prospective, multicenter, observational USOPTIVAL study has been initiated in the United States to examine an investigational cell-free DNA blood test to detect advanced adenoma and colorectal cancer.
A prospective, multicenter, observational USOPTIVAL study (NCT04792684) has been initiated in the United States to examine an investigational cell-free DNA blood test to detect advanced adenoma and colorectal cancer (CRC), according to an announcement from Universal Diagnostics.1
The objective of the research is to evaluate a preliminary panel of biomarkers to see how well it can detect these diseases, as well as to yield supportive data that can inform the development of a final assay.2 Universal Diagnostics, a Spanish in-vitro diagnostics company that develops minimally invasive, blood-based solutions for detecting cancer early on, will conduct the study.
“The start of USOPTIVAL is our first in the United States, so is an important milestone in the development of our blood test for adenomas and early-stage CRC,” Juan Martínez-Barea, cofounder and president of Universal Diagnostics, stated in a press release. “In addition, the study will enable us to build our clinical/medical network in preparation of our pivotal clinical study later.”
For the study, investigators will collect blood samples from a total of 1,100 patients aged between 45 years and 84 years at about 17 clinical trial sites. Study participants will be divided into 2 cohorts. The first cohort will include those with either newly diagnosed CRC, for which resection surgery is scheduled, or suspected advanced adenoma. The second cohort will enroll patients who are at average risk for CRC and have a routine colonoscopy examination scheduled. The performance of a preliminary panel of biomarkers will be examined in both cohorts.
Notably, patients who have a history of aerodigestive or digestive tract cancers or who have undergone surgical removal of portions of their colon for reasons other than CRC are not eligible to participate. Patients with a history of high-risk indications for CRC, including inflammatory bowel disease, familial adenomatous polyposis, hereditary non-polyposis CRC syndrome, or serrated polyposis syndrome, will also be excluded.
This investigational blood test, which is Universal Diagnostics’ first product, aims to prevent CRC through the detection of advanced adenomas. Using next-generation sequencing to profile DNA methylation changes in tissues and plasma samples, investigators were able to establish a proprietary panel of biomarkers which were then combined into targeted assays. These assays have demonstrated a 62.5% sensitivity for adenomas, a 77% sensitivity for CRC, and an 88% to 90% specificity and tissue of origin accuracy in several verification studies.
“USOPTIVAL is scheduled to be completed by the end of 2021, enabling us to conduct the pivotal study of our CRC/AA test,” Martínez-Barea added in the release.