Table 1.

Summary of Pilot Trial outcomes

Pilot Trial outcomes	Analysis	Pass threshold
SQUEEZE
Primary outcomes
1. Participant enrollment ratea   Consent rate for continued participation   Missed eligible patients	Simple proportion Simple proportion Simple proportion	≥2/month(/site) Not applicable Not applicable
2. Protocol adherence: ability to initiate study procedures within 1 h of randomization	Simple proportion	Not applicable
Secondary outcomes
1. Appropriateness of eligibility criteria as evidenced by the ability to identify and enroll participants in a timely manner	Descriptive	Not applicable
2. Completeness of the clinical outcomes of interest to inform the design of the future multicenter trial	Descriptive	Not applicable
3. We will also assess considerations related to study process, resource, and management aspects of feasibility	Descriptive	Not applicable
SQUEEZE-D
Primary outcome
1. The proportion of SQUEEZE participants for whom cell-free deoxyribonucleic acid (cfDNA) can be described	Simple proportion	Not applicable
Secondary outcomes
1. The availability of the required samples from patients enrolled into SQUEEZE and	Simple proportion	Not applicable
2. We will also assess considerations related to study process, resource, and management aspects of feasibility which impact upon the ability to process and test samples to inform the design of a larger-scale study	Descriptive	Not applicable

^aRecognizing that enrollment may be slower during the initial run-in phase