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 |