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Table 3 Measurement timepoints of study objectives

From: Exploring the utility and acceptability of Faecal immunochemical testing (FIT) as a novel intervention for the improvement of colorectal Cancer (CRC) surveillance in individuals with lynch syndrome (FIT for lynch study): a single-arm, prospective, multi-centre, non-randomised study

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

  1. aThis outcome will be measured in a subset of study participants