Date: 2013-12-02
Type of information:
phase: prospective study
Announcement: results
Company: VolitionRX (Singapore) Belgian Volition (Belgium) CHU UCL Mont-Godinne Hospital (Belgium)
Product: non-invasive blood tests for early detection and prognosis of colorectal cancer
Action mechanism:
Disease: colorectal cancer
Therapeutic area: Cancer - Oncology
Country: Belgium
Trial
details: The trial is a prospective longitudinal study including approximately 250 patients as they progress through diagnosis and treatment. The project aims to develop and clinically evaluate non-invasive blood tests for early detection and prognosis of colorectal cancer.
Patient recruitment and sampling will take place in the Gastro-Enterology and Oncology Departments of the CHU UCL Mont-Godinne Hospital. Patients with a potential digestive pathology (including a mixture of suspected colorectal cancer, polyp, inflammatory bowel disease (“IBD”), Crohn’s disease and colitis) will be given a blood test alongside a colonoscopy.
Samples will be taken from the following cohorts:
-Patients with positive colonoscopy for IBD or polyp: initial sample plus a follow-up blood test
- Patients with positive colonoscopy for cancer, and treated as follows:
- Surgery only: initial samples followed by a further blood sample approximately one month after surgery;
- Surgery followed by chemotherapy: initial sample followed by further samples pre and post chemotherapy treatment rounds;
_ Chemotherapy followed by surgery: initial sample followed by further samples pre and post chemotherapy treatment rounds and surgery
Patients with negative colonoscopy for IBD, polyp or cancer will form an age-matched healthy control cohort.
Belgian Volition will analyze the samples using its NuQT™ kits, at its laboratory in Namur, Belgium.
Latest
news: * On December 2, 2013, VolitionRx, a life sciences company focused on developing blood-based diagnostic tests for different types of cancer, has released new data showing that when combining two of its proprietary NuQ® assays into one test, they can achieve 85% detection rates at 85% specificity for colorectal cancer. The data also shows that Volition’s two-assay test can detect more than 50% of precancerous polyps. These new findings come from its ongoing prospective study with CHU Dinant Godinne | UCL Namur Hospital in Belgium.Earlier this month, VolitionRx presented preliminary data from a 90 patient independent trial, later confirmed in a further 113 patients, at University Hospital Bonn in Germany. This data demonstrated 75% detection rates at 70% specificity when using a single NuQ assay. The Belgian team confirmed these results using the same single assay, but when combining it with another nucleosome biomarker they achieved even better results. They have now analysed 39 patients’ samples from the ongoing prospective trial which includes both healthy patients and patients with benign colon disorders. The company hopes to apply for CE mark early next year and FDA approval roughly a year later. * On August 21, 2012, VolitionRX has announced that its subsidiary Belgian Volition has signed an agreement with the Biobank of CHU UCL Mont-Godinne, an academic hospital in Yvoir, Belgium. This is the fourth large-scale external clinical trial for VolitionRX. The trial will begin in early September, and is scheduled for completion next year. The trial will be a prospective longitudinal study including approximately 250 patients as they progress through diagnosis and treatment. The project aims to develop and clinically evaluate non-invasive blood tests for early detection and prognosis of colorectal cancer.
