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