NORTH-REG Dwell-Time Study (NCT04701151) | Clinical Trial Compass
Active — Not RecruitingPhase 4
NORTH-REG Dwell-Time Study
Denmark314 participantsStarted 2021-02-03
Plain-language summary
Previous studies show that the majority NMIBC patients experience side effects to BCG and therefore terminate the instillations before completing all planned instillations. This will increase their risk of recurrence and potential cystectomy. The purpose of this study is to investigate if NMIBC patients who experience severe side effects to BCG instillations will experience fewer or less severe side effects if reducing dwell-time of BCG instillations.
The study will include patients from Denmark, Iceland, Norway and Sweden.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Exclusion Criteria:
* Previous BCG instillations within the last 2 years, because of the risk of not having cleared potential previos side effects.
* 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 progrssion to T1-tumour, T2+\_tumour or cystectomy irrespectievely of indication or development of metastatic urothelial cancer irrespectively of tumour stage
* Contraindications to BCG
* Incontinence
* Bilateral nephrostomy catheters; unilateral nephrostomy catheter is allowed if permanent for the duration of all inistallations with BCG and a normally functioning kidney.
* Need for catheter a demeure 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)
* Reduced immune response (leukaemia, lymphoma)
* Kno…