Date: 2013-05-29
Type of information: Clinical research agreement
Compound: colorectal cancer clinical trials using NuQ® tests
Company: VolitionRx (Singapore) Hvidovre Hospital (Denmark)
Therapeutic area: Diagnostic - Cancer - Oncology
Type agreement: clinical research
Action mechanism:
Disease: colorectal cancer
Details: * On May 29, 2013, VolitionRx, a life sciences company focused on developing blood-based diagnostic tests, announces that it has signed an agreement with Hvidovre Hospital, University of Copenhagen, Denmark, for two colorectal cancer (CRC) clinical trials. The trials will analyze blood samples from approximately 10,800 patients, using VolitionRx’s proprietary NuQ® tests.
The two trials are, as follows:
Retrospective Study: Volition will analyze samples collected in 2010-2012 of approximately 4,800 patients with colorectal cancer, other malignancies, polyps or adenomas, and benign bowel diseases all of whom have undergone a colonoscopy; with full access to all national registries and databases (electronic audit). The trial will commence in June 2013 with a pilot study of 1,000 of these samples.
Prospective Study, to be sponsored jointly by VolitionRx, a top-10 global diagnostics company and the University of Copenhagen: Collection is due to commence in Denmark in April 2014 for a 6,000 patient colorectal cancer screening population trial.
The patient blood samples to be analyzed during the trial have been and will be collected under the direction of Professor Hans Jørgen Nielsen, Professor of Surgical Oncology at the Department of Surgical Gastroenterology at Hvidovre Hospital, part of the University of Copenhagen. They will be provided to VolitionRx blinded and randomized.
Financial terms:
Latest news: * On January 22, 2014, VolitionRx has announced it has commenced blood sample analysis for the first of the two trials. Samples collected in 2010-2012 from approximately 4,800 patients are being entered into a blind retrospective study to further establish the accuracy of VolitionRx’s proprietary NuQ® assays as an initial screening tool for detecting colorectal cancer.
* On November 14, 2013, VolitionRx has announced an increase of 55% (from 6,000 to 11,000) in the number of prospective blood samples to be included in its forthcoming colorectal cancer clinical trial at no additional cost beyond the $1.85 million already announced. The randomised, blinded study is designed to evaluate the validity of VolitionRx’s proprietary NuQ® panel as a first-step screening tool for colorectal cancer.Sample collection for this prospective study, which is jointly sponsored by VolitionRx and the University of Copenhagen, is due to commence in April 2014 and be completed by the end of 2015. With the additional blood samples, 8,000 individuals receiving a positive faecal immunological testing (FIT) result and 3,000 individuals receiving a negative FIT result as part of the Danish national screening programme will now be tested using Volition’s NuQ assay panel. The results will be verified by colonoscopy. Notably, the Danish team is collecting up to 120 data points for each individual included in the trial (e.g. age, gender, other diseases).
The additional blood samples will be collected by Professor Hans Jørgen Nielsen, Professor of Surgical Oncology at the Department of Surgical Gastroenterology at Hvidovre Hospital, part of the University of Copenhagen, and collaborators at 7 additional Danish hospital departments.
In addition to analysing the 16,000 Danish individuals, Volition is carrying out the following trials:
3 ongoing multi-cancer studies at University Hospital in Bonn, Germany; including an 800 patient retrospective study and a 2,000 patient prospective study that involves patients with the 20 most prevalent cancers
a 250 patient study into colorectal cancer at CHU-UCL Mont Godinne Hospital, Belgium.
