Table 3.
Schedule of events prospective Signatera arm(s)
| Enrolment | Week following immunotherapy initiation | |||||||
| Baseline up to 4 weeks prior to immunotherapy Initiation* | Weeks 2–4 |
Weeks 4–8 |
Weeks 8–12 |
Weeks 12–16 |
On treatment follow-up |
Post-treatment follow-up† |
End of study or early termination |
|
| Informed consent | X | |||||||
| Confirmation of inclusion/exclusion criteria and enrolment |
X | |||||||
| Optional future research blood collection (Streck)‡ |
X | X | X | |||||
| Observational/data collection pieces | ||||||||
| Demographics and medical history height |
X | |||||||
| X | ||||||||
| Weight§ | X | X | X | X | X | X | X | |
| Prior and current concomitant medications |
X | |||||||
| Current cancer diagnosis details |
X | |||||||
| Prior and current comorbidities |
X | |||||||
| Laboratory results | X | X | X | X | X | X | X | X |
| Physician assessment of response (RECIST)¶ | X | X | X | X | X | X | ||
| Radiology§§ | X | X | X | X | X | X | X | |
| Pathology results | X | X | X | X | X | X | X | |
| Immunotherapy treatment regimen** | X | X | X | X | X | X | X | |
| Disease status and survival |
X | X | X | X | X | X | X | |
| Cancer treatment procedures | X | X | X | X | X | X | X | |
| Adverse event reporting | X | X | X | X | X | X | X | X |
| Patient disposition | X | |||||||
| Patient-reported outcomes | X | X | X†† | |||||
| HCP questionnaire | X | X | X | X‡‡ | ||||
*Baseline visit may occur the same day as immunotherapy initiation.
†Patients who experience disease progression and those who complete or discontinue immunotherapy treatment will be followed up to 2 years from the date of consent. Data will be collected when available in the medical record.
‡Optional blood collection kit.
§Collect at baseline. For subsequent treatment visits, the weight will be collected from the patient’s medical record, if available.
¶Healthcare provider (HCP) assessment of tumour response based on radiology per RECIST criteria. Performed at an interval determined by HCP.
**Collected at every visit and/or if there is a change in treatment or regimen.
††Patient-reported outcomes are completed at: (1) baseline; (2) after second SIGNATERA blood draws (expected week 4–8) and tumour assessment are complete; (3) month 12, and every 3 months thereafter until study completion for patients continuing immunotherapy treatment.
‡‡HCP questionnaires are completed at: (1) baseline; (2) after second SIGNATERA blood draws (expected week 4–8), imaging and tumour assessment are complete, and all results are discussed with the patient (tumour assessment 1); (3) after the third SIGNATERA blood draw (expected week 8–12), imaging and tumour assessment are complete, and all results are discussed with the patient (tumour assessment 2); (4) any time there is a change in the treatment regimen, indeterminate image finding, or treatment decision to hold or discontinue treatment due to a suspected side effect of immunotherapy.
§§Radiology scans are to be submitted and performed at intervals per standard of care determined by HCP. Reports are collected if available.