NORTH-REG Dwell-Time Study

  • STATUS
    Recruiting
  • End date
    Nov 14, 2023
  • participants needed
    314
  • sponsor
    Jørgen Bjerggaard Jensen
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Updated on 14 February 2021
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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.

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 majority of NMIBC are treated with Bacillus Calmette-Gurin vaccine (BCG) as adjuvant treatment but for carcinoma in situ it is the primary treatment. BCG is known to give a lot of side effects both local and systemic, the severity of these can lead to premature termination of the treatment.

The object of this PhD project is to investigate if reduced dwell time, the time the BCG is in the bladder, will decrease the severity of side effects due to BCG instillations.

This will be investigated in a Nordic setting and the project will be done as a two-armed randomized clinical trial.

By decreasing the severity of side effects, we hypothesize the number of patients completing all planned instillations will increase and thereby decrease the risk of the BC evolving into a more aggressive type.

Details
Condition Side Effect of Drug
Treatment Bacillus Calmette Guerin
Clinical Study IdentifierNCT04701151
SponsorJørgen Bjerggaard Jensen
Last Modified on14 February 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
T1 tumors where re-resection had not been performed
TUR-B, bladder biopsy or traumatic catheterization within 2 weeks
Previous or current MIBC
Previous or current metastatic urothelial carcinoma
Contraindications to BCG
Incontinence
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
Previously radiation therapy of the bladder
Known with another cancer diagnosis, except prostate cancer
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
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