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Table 2 Timeline, study treatment, study visits and medical procedures

From: Study protocol of a phase II clinical trial of oral metformin for the intravesical treatment of non-muscle invasive bladder cancer

Required Investigations

Prestudy

Telephone calls

6 weeks after start treatment

3 months after start treatment (end of treatment)

Written informed consent

X

   

Demographics

X

   

Overall medical history

X

   

ECOG/WHO performance status

X

X

X

X

Adverse events

 

X

X

X

EORTC QLQ-NMIBC24

X

 

X

X

SF-36 quality of life

X

 

X

X

Medication diary

 

X

X

X

Physical:

    

 Physical examination

X

 

X

X

 TURB

X

  

X

Haematology:

    

 Complete blood counts

X

 

X

X

 PT, APTT

X

   

Clinical chemistry:

    

 Renal function

X

 

X

X

 Liver function

X

 

X

X

 Serum glucose

X

 

X

X

 HbA1c

X

  

X

 Insulin

X

  

X

 IGF-1

X

  

X

 IGF binding protein-3

X

  

X

Other Investigations:

    

 Metformin concentration in serum

  

X

X

 Metformin concentration in urine

  

X

X

 Urinalysis

X

 

X

X

 Pathological review of biopsies

X

  

X

  1. Abbreviations: ECOG Eastern Cooperative Oncology Group, IGF insulin growth factor, WHO World Health Organisation