Patients
ICH, glioma, tumor
TUMOR, ADVERSE EVENTS, RECRUITMENT, MAY, GLIOMA, PATHOLOGY
123 patients affected by recurrent GBM or grade III glioma were screened in this parallel-group randomized controlled clinical trial at 13 clinical sites across the US over a period of three years and assessed for inclusion and exclusion criteria to participate in the study (78 recurrent GBM patients were enrolled in the study (Consort Diagram – Subjects underwent surgical resection and biopsy. For histopathology confirmation and diagnosis of GBM, MGMT gene methylation status, and IDH-1/2 status, fresh tissue tumor biopsies from rGBM patients were sent to the sites’ hospital pathology lab for processing. The central ChemoID laboratory conducted the drug response assay using a second portion of the fresh biopsies. In accordance with CLIA and CAP requirements, samples were shipped to the ChemoID laboratory utilizing a secure FedEx overnight shipping container for clinical specimens. All recurrent GBM patients who registered for the trial underwent the ChemoID assay and were randomly assigned by the sites’ coordinators to a study group using a computer-generated algorithm (in REDCap).The patients were treated either with the standard of care chemotherapy chosen by the physician (ARM 1) or treatment directed by the ChemoID assay (ARM 2), depending on the randomly allocated study group. Data collection was performed by a REDCap electronic data capture application software.Chemotherapy medications were administered in accordance with the trial group to which each patient was assigned. Over the course of treatment, assessments of adverse events and drug compliance were made. Enrollment in the trial began in May 2018 after the lead institution completed the trial start-up procedures. Our trial was registered on The study protocol was approved by the Western Institutional Review Board (WIRB) and each of the independent ethics committees of the participating institution. This study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP) requirements described in the current revision of the International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidelines and all applicable regulations, including current United States Code of Federal Regulations (CFR), Title 21, Parts 11, 50, 54, 56, and 312 and Title 45, Part 164. The IRB reviewed and approved the site’s informed consent form (ICF), and any other written information that was used for patient recruitment. All patients signed the informed consent before enrollment.