Curebase and Persephone Biosciences have announced a partnership to conduct a long-term decentralised clinical trial (DCT) to develop improved therapy options and prevention strategies for colorectal cancer (CRC) patients.
The DCT entails stool and blood sample collection from 350 trial subjects with CRC and 1,000 healthy individuals who are considered as either reduced or high risk for CRC.
Anticipated to commence early this year, the trial is part of a longitudinal, observational ARGONAUT study.
Nearly 4,000 individuals with advanced-stage cancer, as well as healthy people who are either at low or high risk for the disease, will be part of the study.
Under a partnership with Janssen Research & Development, a key priority of the ARGONAUT study and specifically the CRC patient cohort is to guarantee at least 50% of subjects are from different populations.
Curebase’s DCT model allows more diversified studies by including unique populations typically underrepresented in trials.
The virtual research sites of the company also offer doctors new options to offer their patients, irrespective of the location.
The Curebase platform enables CROs, sponsors and doctors from all sizes of practices to carry out clinical research, which include independent clinics, large academic research sites and private practices.
The companies are establishing more than 30 centres in the US to enrol subjects for the CRC study and obtain electronic data from patients.
Findings obtained may be utilised for developing precision microbiome therapeutics and for identifying cancer-specific biomarkers, which are clinically actionable, for direct decisions on the treatment.
The ARGONAUT study results could also offer an improved understanding of the role of the gut microbiome in response of the patients to cancer treatments.
This may eventually lead to adjuvant therapy development or a precision treatment approach to oncology interventions in the future.
Persephone Biosciences co-founder and CEO Dr Stephanie Culler said: “A trial of this size, in which 50% of participants are planned to comprise racial and ethnic minorities, is unprecedented in both scale and ambition.
“Curebase has helped Persephone secure community study sites throughout the US that meet our diversity and inclusion criteria while, at the same time, providing these sites with a DCT platform and virtual staff support that makes their participation in our trial easy.”