E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with non muscle invasive bladder cancer in their first year after the diagnosis.
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E.1.1.1 | Medical condition in easily understood language |
Examination and follow up in patients with non muscle invasive bladder cancer. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005004 |
E.1.2 | Term | Bladder cancer NOS |
E.1.2 | System Organ Class | 100000004864 |
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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 |
The Hypothesis of this study is that the use of PDD in the outpatient clinic in patients with a high recurrence risk undergoing follow-up flexible cystoscopy will result in diagnosis of papillomas earlier than by the use of conventional flexible cystoscopy in white light. Thus, a higher number of tumours can be treated in the outpatient setting without the need for procedures in general anaesthesia. Furthermore, the number of follow-up cystoscopies can be reduced if PDD is used at the first cystoscopy following TURB. |
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E.2.2 | Secondary objectives of the trial |
Primary end points: To see if there has been any recurrences at 8 months and 12 months cystoscopy in both groups.
Secondary end points: Number of procedures in general anesthesia within the first 12 months after the first transuretral resection (TUR-B). tumor recurrence and size. tumor progression stage. identification of flat dysplasia and CIS. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
age over 18 years first time TUR-B where the pathology showed Ta ( LG and HG) informed consent on the basis of oral and written information |
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E.4 | Principal exclusion criteria |
lack of consent communication problems missing or incomplete implementation of the procedure and Hexvix installation active cystitis catheter in the bladder ( chronic) AK treatment apart from aspirin Treatment with BCG in the meantime between TUR-B and study inclusion |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end points: To see if there has been any recurrences at 8 months and 12 months cystoscopy in both groups.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary end points: Number of procedures in general anesthesia within the first 12 months after the first transuretral resection (TUR-B). tumor recurrence and size. tumor progression stage. identification of flat dysplasia and CIS. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | No |
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 white light cystoscopy |
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E.8.2.4 | Number of treatment arms in the trial | 348 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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 | No |
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 | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 18 |