Table 2.
Schedule of enrolment, interventions and assessments (the responsible person is stated in brackets). As resectability of the tumor is a prerequisite to obtain tissue samples, the day of surgery (day 0) is the time point of allocation. Day of discharge (dis). Month (m)
STUDY PERIOD | ||||||||
---|---|---|---|---|---|---|---|---|
Enrolment | Allocation | Post-allocation | Close-out | |||||
TIMEPOINT | until − 1 | 0 | 0 | dis | 6 m | 12 m | 18 m | 24 m |
ENROLMENT: | ||||||||
Eligibility screen (surgeon) |
X | |||||||
Informed consent (surgeon) |
X | |||||||
Allocation (surgeon) |
X | |||||||
INTERVENTIONS: | ||||||||
Take 15 ml blood sample
(surgeon) |
X | |||||||
Prepare tumor tissue samples (pathologist) | X | |||||||
ASSESSMENTS: | ||||||||
Diagnosis of PDAC
(surgeon) |
X | |||||||
Demographic data, operation procedure, complications | X | |||||||
Recurrence pattern, survival time, adjuvant tumor therapy and hospital admissions | X | X | X | X |