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Table 2 Visit schedule and assessments

From: The ASAMET trial: a randomized, phase II, double-blind, placebo-controlled, multicenter, 2 × 2 factorial biomarker study of tertiary prevention with low-dose aspirin and metformin in stage I-III colorectal cancer patients

Assessments

  

Treatment Period

 
 

Screening1

Randomization

Baseline

4 Months

8 Months

12 Months

End of study visit

Informed consent

X

      

Inclusion/exclusion criteria

X

      

Relevant medical history

X

      

Prior medication/therapy of current CRC

X

      

Physical exam, vital signs and ECOG performance status

X

 

X

X

X

X

X

Hematology, biochemistry, and coagulation profile

X2

 

X2

X2

X2

X2

 

Randomization

 

X

     

Blood collection for biological assessment

  

X

  

X

 

Blood collection for TxB2/metformin quantification3

  

X

X

X

X

 

Feces collection4

  

X

  

X

 

Questionnaires (FACIT, HADS, Distress, IPAQ, and EPIC [4])

  

X

  

X

 

Colonoscopy and biopsies

  

X5

  

X5

 

Adverse events

X6

 

X

X

X

X

X

Concomitant medication

  

X

X

X

X

 

Study treatment supply

  

X

X

X

  

Compliance (via pill count)

   

X

X

X

 
  1. 1. Within 28 days after day 1
  2. 2. Complete blood count (WBC, white blood cell differential count, RBC, Hb, Ht, MCV, MCH, MCHC, RDW, PLT, and MPV), alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, fasting glucose, triglycerides, and cholesterol. Coagulation profile (coag) includes: (International Normalized Ratio) INR, Activated Partial Thromboplastin Time (APTT), prothrombin time (PT), and fibrinogen. At baseline, hematology, biochemistry, and coagulation profile are not needed if the screening visit is performed within 7 days prior to the baseline visit.
  3. 3. TxB2/metformin quantification will be performed at the end of the study
  4. 4. Only for Italian patients
  5. 5. During the colonoscopies at baseline and at 12 months, the occurrence of adenoma (low, intermediate, and/or high grade intraepithelial neoplasia) as well as the histopathological subtype (e.g. tubular, villous, tubulovillous, sessile serrated, traditional serrated, or hyperplastic) will be determined upon routine histopathological analysis according to local practice (i.e. according to the Vienna classification of gastrointestinal epithelial neoplasia). If at least two adenomas with different grading exist, the highest grade will be considered, e.g. occurrence of two intermediate-grade and one high-grade adenoma would result in a categorization as high-grade
  6. 6. Adverse event (trAE) reporting will begin on the date the patient provides informed consent to participate in the study (documentation in the eCRF will only be done for randomized patients) and end 30 days after last study drug dose or at the end-of-study visit, which ever occurs first. During the screening phase, only AEs deemed to be serious (SAEs) and related to protocol and not routinely performed procedures have to be reported
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BMC Cancer

ISSN: 1471-2407

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