Bladder Cancer Prognosis Programme (incorporating SELENIB trial)
- Conditions
- Bladder cancerBCPP - bladder cancer (superficial and invasive)SELENIB - superficial bladder cancerCancer
- Registration Number
- ISRCTN13889738
- Lead Sponsor
- niversity of Birmingham (United Kingdom)
- Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37847504/ (added 23/10/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 270
Inclusion criteria for SELENIB Trial:
1. Able to give informed consent for SELENIB
2. Previously registered onto the Bladder Cancer Prognosis Programme
3. Disease characteristics: histopathologically confirmed non-muscle invasive transitional cell carcinoma. Solitary grade 1 pTa larger than 3 cm and all other stage pTa, pT1 or pTcis
Exclusion criteria for SELENIB trial:
1. Disease characteristics - solitary grade 1 pTa <3 cm or stage pT2 and above
2. Patients that are pregnant or breastfeeding
3. Patients diagnosed with human immunodeficiency virus (HIV) infection
4. Patients who are on immunosuppressive therapy following organ transplantion
5. Patients taking cyclosporin
6. Any condition, which, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the trial objectives
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SELENIB trial - primary outcomes<br>1. Recurrence-free interval<br>2. Progression-free interval<br><br>Progression is defined as a recurrence with:<br>1. An increase in grade from grade 1/grade 2 to grade 3<br>2. An increase in tumour, node, metastasis (TNM) stage<br> 3. The new occurrence of carcinoma in situ (CIS) in a bladder previously free from such lesions<br>4. The new occurrence of multiple urothelial tumours following resection of a solitary urothelial tumour<br>5. The need for a cystectomy because of refractory disease
- Secondary Outcome Measures
Name Time Method