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Table 1 Study schedule

From: Clinical trial protocol of the ASTER trial: a double-blind, randomized, placebo-controlled phase III trial evaluating the use of acetylsalicylic acid (ASA) for enhanced early detection of colorectal neoplasms

Trial-specific procedures

Screening

Baseline

Treat-ment

Observation

Post-study

Timeline

  

Day 0

Day 2

Day 3

Day 4

Colonoscopy from day 5 onwards

Informed consent

X

      

Inclusion/ exclusion criteria

X

      

Randomization

X

      

Physical examination

X

      

Patient parametersa

X

      

Blood sampling for biomarker analyses (optional)e

X

      

Questionnaireb

X

      

Handing over stool collection material and subject diaryc

X

      

Drug administration (Acetylsalicylic acid or placebo)

  

X

    

Stool sampled (FOBGold®Tube Screen)

 

X

 

X

X

X

 

Stool sampled (FD Hb/Hp Complex)

 

X

 

X

X

X

 

Concomitant therapy recording

  

X

X

X

X

 

(S)AE recordingf

  

X

X

X

X

 
  1. aAge, sex, weight, height, and blood pressure
  2. bThe questionnaire includes questions on family history of CRC and lifestyle factors such as smoking and alcohol consumption
  3. cEight kits are handed over
  4. dIf stool collection on these days is not possible because of constipation or other reasons, stool collection may be postponed to the subsequent days; participants are also allowed to collect only two stool samples, which should be at baseline (without medication) and on day 2, if possible
  5. eBlood sampling for biomarker analysis: 2 EDTA tubes; 2 serum tubes
  6. fInterview of participants before colonoscopy