EUCTR2020-003112-27-SE
Active, Not Recruiting
Phase 1
ordic Urothelial Cancer Research Group Study on Reduced BCG Dwell-Time in High Risk NMIBC Short title: NORTH-REG Dwell-Time Study - DWELL-TIME
ConditionsReduced BCG dwell time in patients who are diagnosed with high risk non-muscle-invasive- bladder cancerMedDRA version: 20.0Level: LLTClassification code 10005004Term: Bladder cancer NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsBCG medac
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Reduced BCG dwell time in patients who are diagnosed with high risk non-muscle-invasive- bladder cancer
- Sponsor
- Aarhus University
- Enrollment
- 314
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\=18 years of age at the time of signing the Informed Consent Form
- •Signed Informed Consent Form
- •Patients with NMIBC where BCG therapy including maintenance for 1 year is planned for one of the following histopathological findings:
- •Ta high grade without CIS
- •CIS with or without previous or concomitant Ta tumors
- •T1 with or without CIS
- •Is, according to the Investigator’s judgement, able to comply with the trial protocol
- •Ability to understand the Patient Information Sheet orally and in writing
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •Previous BCG instillations
- •T1 tumors where re\-resection had not been performed
- •TUR\-B, bladder biopsy or traumatic catheterization within 2 weeks.
- •Previous or current MIBC
- •Progression defined as progression to T1\- tumour, T2\+\-tumour or cystectomy irrespectively of indication or development of metastatic urothelial
- •cancer irrespectively of tumour stage
- •Contraindications to BCG
- •Incontinence
- •Need for catheter at the time of instillation
- •Immune Suppressing medication (cancer therapy e.g cytostatic medicinal products, radiation, local and systemic steroids like e.g. prednisolone is permitted)
Outcomes
Primary Outcomes
Not specified
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