Status:
ACTIVE_NOT_RECRUITING
NORTH-REG Dwell-Time Study
Lead Sponsor:
Jørgen Bjerggaard Jensen
Collaborating Sponsors:
Aarhus University Hospital
Herlev Hospital
Conditions:
Side Effect of Drug
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ri...
Detailed Description
Approximately 8,000 patients are diagnosed with bladder cancer (BC) in the Nordic countries every year. The majority of BC patients are diagnosed with non-muscle invasive bladder cancer (NMIBC). The m...
Eligibility Criteria
Inclusion
- ≥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
- 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)
- Known allergy or sensitivity to BCG
- HIV infection
- Signs of active tuberculosis
- Any type of previosly radiation therapy involving the bladder.
- Concomitant invasive cancer within 5 years other than non-melanoma skin cancer and protate cancer without metastasis
- Current urinary tract infection
- Patient with visible hematuria
- Current alcohol and/or drug abuse
- Has a mental or legal incapacitation or another condition which impair the subject's ability to participate
- Has participated in another interventional clinical study and treatment with another investigational product 30 days prior to randomization
- For women study subjects: Pregnancy or breastfeeding
- For women Study subjects of childbearing potential: unless they are using highly effective methods of contraception from the first BCG instillations until 14 days after last dose of BCG treatment, which are defined as total abstinence, female sterilization, use of oral methods of contraception or placement of an intrauterine contraception devices.
- For male Study Subjects: unless they are using highly effective methods of contraception from the first BCG instillation until for 14 days after last dose of BCG treatment, which is defined as total abstinence or use of condoms.
Key Trial Info
Start Date :
February 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT04701151
Start Date
February 3 2021
End Date
December 1 2030
Last Update
June 25 2024
Active Locations (11)
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1
Aarhus University Hospital
Aarhus, Aarhus N, Denmark, 8200
2
Department of Urology, Aalborg University Hospital
Aalborg, Denmark, 9100
3
Department of Urology, Rigshospitalet
Copenhagen, Denmark, 2100
4
Herlev Hospital
Herlev, Denmark