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 |