April 20, 2021 – Holy Cross Health is now enrolling patients in a colorectal cancer trial (BESPOKE CRC), a prospective, multi-center trial that will enroll 1,000 or more patients at the time of surgery to measure the clinical impact of serial blood-based testing with Signatera, earlier relapse detection, and better patient risk stratification after surgery. .jpg)
Signatera is a personalized, tumor-informed assay optimized to detect circulating tumor DNA (ctDNA) for molecular residual disease assessment and recurrence monitoring for patients previously diagnosed with cancer, with broad utility for cancer management.
According to Paul Papagni, JD, Executive Director Research, at Holy Cross Health, this is a personalized test of the genetics of the tumor matched to a blood test. “We are determining through a blood test the presence or absence of tumor DNA afNA after surgery,” Papagni said.
In published validation studies, Signatera detected relapse in patients with Stage II-III CRC up to 16.5 months earlier (an average 8.7 months earlier) than standard diagnostic tools including CT imaging and CEA. In May 2019, the FDA designated Signatera as a Breakthrough Device, and in September 2020, Medicare issued final Local Coverage Determination for patients diagnosed with Stage II or Stage III colorectal cancer. There are estimated to be 145,600 new CRC diagnoses per year in the U.S. and more than one million CRC survivors.
This trial is one of many underway at the Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross, which offers disease-specific care in all oncology sub-specialties including medical, surgical and radiation oncology. The Cancer Center also offers research trials that span from early drug development through the later Phase 4 stages for multiple types of cancer. For more information, call the research office at 954-267-7750 or visit www.holycrosscancer.com.
ABOUT HOLY CROSS HEALTH
A member of Trinity Health, Fort Lauderdale-based Holy Cross Hospital, dba Holy Cross Health, is a full-service, non-profit, Catholic, teaching hospital operating in the spirit of the Sisters of Mercy. Holy Cross has been named one of the top 10 hospitals in the Miami metro area and among the top 30 in the state in U.S. News and World Report’s 2020-2021 Best Hospital rankings. Through strategic collaborations and a commitment to being a person-centered, transforming, healing presence, the 557-bed hospital offers progressive inpatient, outpatient and community outreach services and clinical research trials to serve as our community’s trusted health partner for life. Holy Cross Health also encompasses Holy Cross HealthPlex outpatient facility, urgent care centers and more than 50 Holy Cross Medical Group physician practices. To learn more about Holy Cross Health, visit holy-cross.com. Connect @holycrossfl.
