The Akron Legal News

OSU launches clinical trial for early breast cancer detection

ELISSA COLLOPY
Special to the Legal News
Published: April 18, 2016

The Stephanie Spielman Comprehensive Breast Center at The Ohio State University will begin a clinical trial for early breast cancer detection after Cyrcadia Health announced its expansion plans April 5.

The trial began in 2015 in Mountain View, Calif., at El Camino Hospital, and will continue research at both locations.

There will be 173 patients enrolled, with institutes focused on breast cancer health screenings.

“We are targeting both the 70 percent of the population that undergo biopsies on non-cancerous tissue resulting from mammographic referral and mass screening of patients with dense breasts,” Rob Royea, president of Cyrcadia Health said. “Patients with dense breast tissue have a higher propensity for cancer; furthermore, mammography is challenged by detecting cancer in dense breast tissue as the tissue itself can mask cancer cells and lesions.”

The collected results are transferred to a global cancer library where advanced analytical analysis occurs and the results are communicated back through a smart device to the physician and patient.

“We have had a great deal of interest in this technology that may change the need for a breast biopsy,” said Dr. Shyamali Singhal, founder of the El Camino Hospital Cancer Center. “The trial at El Camino Hospital opened with strong interest from the patient population and the early results are indeed promising. We look forward to further involvement with the Cyrcadia study ...”

One in eight women in the U.S. are diagnosed with breast cancer annually, and with a high rate of deaths, many occur due to lack of early detection. About 500,000 women die worldwide from breast cancer every year.

That is why Cyrcadia has implemented a trial for early detection.

Its technology, a wearable, smart-phone enabled iTBraTM collects between two to 12 hours of breast cell data by a data collection device placed under a woman’s bra.

Any abnormalities are identified at the earliest stage of cellular change over time by a Cyrcadia-patented process that measures circadian rhythm-based temperature variances of cell cycles.

“The expansion of our study to The Ohio State University is truly exciting, as (they were) the point of origin for the initial 500 patient study conducted with our previous FDA cleared device,” Royea said.

Dr. William Farrar, a professor in the division of surgical oncology, department of surgery, and medical director of the Stefanie Spielman Comprehensive Breast Center was an original researcher for Royea and Cyrcadia.

“His confidence to include the Cyrcadia study at one of the nation’s highest rated cancer hospitals is a significant complement to our early clinical trial progress,” he said.

The Canary Foundation, the only foundation in the world that focuses solely on early cancer detection, is financially supporting Cyrcadia’s trials.

The formed a partnership between the two entities on early biomarker identifications for breast cancer using Cyrcadia’s findings.

These could lead to earlier therapy intervention in breast cancer’s progression.

“We are looking forward to participating in the Cyrcadia study,” said Farrer. “Early indications from the original predicate device from (them) showed promise that the monitor may be useful for screening those women with (dense breast tissue).”

As Cyrcadia evaluates the information from The Ohio State University’s cancer center and potentially adds new sites to the study, final results will be posted online at clinicaltrials.gov once clearance from the FDA is released or final trial enrollment.

The Stefanie Spielman Comprehensive Breast Center at The Ohio State University is the first of its kind in the Midwest, offering full continuum breast cancer care from prevention and screens, to detection, diagnosis, treatment and survivorship in the same facility.

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