TABLE 1.

Primary and secondary endpoints.

Primary study endpoint (key phases)	Primary outcome measure
Diagnostic efficiency (retrospective and prospective phases)	Percentage of acute leukemia patients for whom all mandatory and highly recommended genetic variants found by SoC methods are also detected by WGTS*
Improved diagnostic yield (retrospective and prospective phases)	Percentage of acute leukemia patients for whom genetic variants relevant for classification or risk stratification are identified by WGTS* but not by SoC
Secondary study endpoints (key phases)	Secondary outcome measure
Technical feasibility (retrospective and prospective phases)	Percentage of patients for whom WGTS* analysis and interpretation is successful
Clinical feasibility for routine implementation (real-time validation phase)	Percentage of patients for whom WGTS analysis and interpretation is successful within a given time frame
Clinical utility (prospective and real-time validation phases)	Percentage of acute leukemia patients for whom patient management and/or therapy decision is/could be changed based on variants detected only by WGTS
Health-economic efficiency (all phases)	Micro-costing and cost effectiveness analysis of WGTS* compared to SoC

*For the retrospective phase, only WGS data are available.