- "By combining our resources, we're able to proceed with what is the world's largest and most thorough evaluation of colon cancer pathology and metabolic risk factors ever performed in the history of medicine," said Dr. Dayan Goodenowe, CEO of the Saskatoon company.
Speaking at a Wednesday news conference, he said Phenomenome's research has indicated 90 per cent of people who have colon cancer have a metabolic deficiency. Based on six years of research that involved more than 1,000 people worldwide, the company has developed a highly validated blood test to identify who has the deficiency.
The two-year trial will begin at the Pasqua and General hospitals [in Regina] and will involve 5,000 patients".
- Robert Hilsden, MD, from the University of Calgary is conducting an investigator sponsored clinical trial using Phenomenome's gTA test. This prospective cohort study will be conducted at the Forzani Charities Colon Cancer Screening Centre (CCSC) in Calgary. The study protocol has a two arm design to evaluate average and moderately high risk subjects with no known colon pathology and a smaller sub-study of CRC positive subjects.
The primary aim of the first component of the study is to assess the diagnostic accuracy of the gTA test in detecting CRC in asymptomatic persons scheduled for a screening colonoscopy based on fecal occult blood results. The second component of the study will focus on the gTA levels of CRC positive subject's pre and post-surgery to determine effects of tumor resection. All study subjects will be followed longitudinally for three years with additional gTA tests and colonoscopies based on the initial results. The goal is to enroll 1300 subject in the first arm of the study and 150 CRC-positive subjects in the second arm of the study.
This study is scheduled to begin in 2008.