Table 3.
Measurement timepoints of study objectives
| Study Objectives | Measurement Timepoints | |||||
|---|---|---|---|---|---|---|
| Objective Type | Objective Summary | Baseline (Y0) | Y1 | Y2 | Y3 | Passive Follow-Up (Y4-Y7) |
| Objective 1 (Primary) | To evaluate the specificity of FIT for the detection of CRC and AA’s in patients with LS. | x | x | x | x | |
| Objective 2 (Secondary a) | To identify and explore acceptability, views, and preferences of FIT in this patient population | x | ||||
| Objective 3 (Secondary b) | To evaluate the sensitivity of FIT for the detection of CRC in patients with LS | x | x | x | x | |
| Objective 4 (Secondary c) | To evaluate the sensitivity of FIT for the detection of AA’s in patients with LS | x | x | x | x | |
| Objective 5 (Exploratory) | To examine and characterise the faecal microbiome of patients with LS. | x | x | x | x | |
| Objective 6 (Exploratory) | To observe the incidence of interval CRCs for LS patients with FIT negative results (< 6 μg/g f-Hb) | xa | ||||
aThis outcome will be measured in a subset of study participants