By Clinical Informatics News Staff

April 20, 2017 | GRAIL today announced that it has commenced its second multi-center clinical study, the STRIVE Study (NCT03085888), to facilitate the development of GRAIL’s blood tests for early-stage cancer detection. STRIVE is a longitudinal, prospective, observational study that will enroll up to 120,000 women at the time of their screening mammogram to train and validate a blood test to detect breast cancer. Additionally, the study will be used to develop a pan-cancer test to detect multiple cancers at early stages.

“Breast cancer that is detected early can be treated more effectively. GRAIL aims to develop a blood test to enhance existing methods of breast cancer screening, with the goal of improving patient outcomes by more accurately identifying patients who need further evaluation for cancer,” Mark Lee, GRAIL’s Head of Clinical Development and Medical Affairs, wrote. “We are committed to developing a deep understanding of cancer biology and rigorously evaluating our tests for validity and utility through large studies such as STRIVE.”

The STRIVE Study will enroll women at Mayo Clinic and throughout the Sutter Health system that serves Northern California, and will collect baseline blood samples from women at the time of their screening mammogram.

“Breast cancer is the most common cancer in women in both developed and less developed countries around the globe. Despite many medical and therapeutic advances in treatment, approximately 40,000 women in the U.S. will die from breast cancer this year and many others will require treatment for advanced disease,” said Steven Cummings, Professor of Medicine and Epidemiology & Biostatistics (Emeritus), UCSF, and Senior Scientist, California Pacific Medical Center Research Institute, Sutter Health, in a statement. “I am excited to be part of this initiative to apply new technology to the possibility of detecting breast cancer, and other cancers, at earlier stages.”

“In order to develop and validate a blood test for the early detection of breast cancer, we need the participation of up to 120,000 women. GRAIL’s cutting-edge clinical technology enables us to enroll at scale and speed while collecting high-quality clinical outcomes data,” GRAIL’s Head of Clinical Development, Anne-Renee Hartman, commented in an official statement.