At this stage of the project, the Endeavor consortium has reached consensus on the design of the study. In collaboration with different stakeholders, such as physicians, epidemiologists, patient representatives, biologists, local and national protocols governing the treatment and surveillance of early-stage Barrett's esophagus cancers were scrutinized. A consensus on a unified study protocol was forged for patient tailored treatment based on the biomarker outcomes versus standard surveillance in the control arm of the RCT study.
Beside preparing the RCT study protocol, all the necessary processes were conducted to successfully conduct the prospective pilot cohort study. A general protocol and informed consent form for the pilot study were made, subsequently adapted to national regulations by each recruiting site and submitted to the local ethical committees. Besides ethical documents, legal documentation such as clinical trial agreements and material transfer agreements were drafted and signed by the partners. On a technical level, the consortium developed an electronic case report form to correctly capture all study data and guarantee secure data storage and quality. In addition, e-clinical tools were developed for the assessment of health related patient quality of life and cancer-related anxiety. Parallel to the technical developments, the consortium members investigated how to establish the best methods regarding tissue and blood sampling procedures, and sample analysis procedures. A detailed sample flow was set up, as well as infrastructure to guarantee secure storage of the study samples in the central biobank and timely shipment of the samples for analysis in several laboratories. Lastly, logistical preparations were performed to ensure a smooth execution of the clinical trial: preparation and finalization of standard operating procedures and an extensive study manual, testing sample shipments, finalizing courier arrangements, ordering materials and assembling study lab kits at the central biobank. The first site initiation visits for the pilot study have been performed, paving the way for a successful execution of the pilot study.
