Table 1.

Schedule of investigations/assessments in PHOTO trial

Visit/assessment	Pre-randomisation screening	Pretreatment	TURBT	Prior to discharge	Surveillance									At first disease recurrence /progression
					Second TURBT (as clinically indicated)	3 months post-treatment	6 months post-treatment	9 months post-treatment	12 months post-treatment	18 months post-treatment	24 months post-treatment	36 months post-treatment	Annually thereafter
Visual diagnosis of IR/HR NMIBC	X												According to EAU guidelines	Treatment according to local practice
Medical history	X
HRQoL questionnaire*		X		X	X	X†	X†	X†	X†	X†	X†	X†
TURBT according to treatment allocation with post-treatment MMC instillation			X
Second TURBT, if required, according to treatment allocation					X
Assessment of adverse events (CTCAE and Clavien Dindo)						X
Cystoscopy						X	X	X	X	X	X	X
Histological confirmation of recurrence/progression														X
Collection of FFPE tissue‡			X											X
Urine sample collection‡		X				X			X		X	X		X
Blood sample collection‡		X				X			X		X	X		X

*European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30), European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Non-Muscle-Invasive Bladder Cancer (QLQ-NMIBC24) (NMIBC24) and EQ-5D-3L.

†Questionnaire sent by post directly to participant.

‡If patient consented to participation in PHOTO-T (as this is archived pathology the tissue may be requested at an interval from the diagnostic resection/recurrence).

CTCAE, Common Terminology Criteria for Adverse Events; FFPE, Formalin-Fixed, Paraffin-Embedded; HR, High risk; HRQoL, health-related quality of life; IR, Intermediate risk; MMC, Mitomycin-C; NMIBC, non-muscle invasive bladder cancer; PHOTO-T, PHOTO Translational; TURBT, Transurethral resection of bladder tumor.