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

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

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

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

ISSN: 1471-2407