E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Superficial Bladder Cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005003 |
E.1.2 | Term | Bladder cancer |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To test the hypothesis that photodynamic assisted resection of superficial bladder cancer reduces the recurrence rate. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Three subsidiary studies would form a histological assessment of the tumours diagnosed on white light versus those diagnosed on blue light cystoscopy as follows;
i) In patients following a course of intravesical BCG (intravesical chemotherapy) (33 patients). ii) Patients with malignant or suspicious cells on urine cytology but no evidence of disease on previous investigation (44 patients).
OBJECTIVE OF i) and ii) 1) To determine if we can increase the diagnostic accuracy of the bladder biopsy by using a photodynamic technique to direct the surgeon to bladder tumour or carcinoma in situ in problematic cases as described.
iii) In patients with recurrent bladder tumours (35 patients). Following initial treatment 20-40% of patients will be diagnosed with recurrent tumour. This may be because the primary tumour is incompletely resected, or that tumour is not recognised.
OBJECTIVE of iii) To determine the histology of tumours in patients presenting with recurrent bladder tumour in both white light and photodynamic cytoscopy. |
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E.3 | Principal inclusion criteria |
Randomised Trial: New patient with superficial bladder transitional cell carcinoma (TCC) for transurethral resection
Subsidiary studies: i). Patient for check cystoscopy following a course of BCG for superficial bladder tumour. ii). Previous investigation: upper tract imaging, cystoscopic assessment. Positive urine cytology. iii). Recurrent bladder tumour diagnosed on flexible cystoscopy and/or suspected by positive urine cytology.
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E.4 | Principal exclusion criteria |
Randomised Trial: Previous bladder tumour or upper tract TCC Previous bladder surgery Life expectancy less than one year
Subsidiary studies: None
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E.5 End points |
E.5.1 | Primary end point(s) |
Randomised trial: Check cystoscopy at one year
Subsidary Studies: Diagnosis of additional histologically confirmed tumour when using bluelight cystoscopy over white light cystoscopy |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Conventional cytoscopy and resection |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |