Schedule of events
| Enrolment | Adjuvant setting (postsurgery observation or postoperative systemic therapy) | Surveillance setting (~month 6 onwards) | End of study or early termination | ||||
| Presurgery—14 days | Up to 6 weeks postsurgery | Week 6±14 days¶ | Week 12±28 days¶ | Week 20±28 days¶ | Every 3 months through year 2±45 days¶ | ||
| Informed consent | X | X | |||||
| Confirmation of inclusion/exclusion criteria and enrolment | X | X | |||||
| Future research blood collection (streck)¶ | X | X | |||||
| Demographics | X | ||||||
| Medical history | X | ||||||
| Height | X | ||||||
| Weight | X | X | X | X | X | ||
| ECOG performance status | X | ||||||
| Laboratory results | X | X | X | X | X | X | X |
| Radiology results | X | X | X | X | X | X | |
| Pathology results | X | ||||||
| Healthcare provider questionnaire | X | X‡ | X§ | ||||
| Systemic therapy* | X | ||||||
| Adverse event reporting | X | X | X | X | X | X | |
| Patient-reported outcomes | X | X† (month 6, 12, 18, 24) | |||||
*Patients receiving postoperative systemic therapy only.
†Every other appointment or every 6 months.
‡Data to be captured after receipt of Signatera results, either after patient completes their postoperative (which may be greater than 20 weeks±4 weeks) or after the treatment plan to observe during the adjuvant setting.
§To be completed at the end of year 2, cancer recurrence or early withdrawal (whichever occurs first). Grey box indicates measurement taken only once during the shaded (grey) time period.
¶Optional
ECOG, Eastern Cooperative Oncology Group.