CTIS2023-505936-37-00进行中（未招募）1 期
ordic Urothelial Cancer Research Group Study on Reduced BCG Dwell-Time in High Risk NMIBC
Aarhus University Hospital0 个研究点目标入组 101 人开始时间: 2023年6月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 101
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •above 18 of age at the time of signing the informed consentform, Signed informed consent form, Patients with NMIBC where BCG therapy including maintanence 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 tumours; 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
排除标准
- •previous BCG instillation with the last 2 years, due to risk of not having vcleared potential previous side effects, Patient with visible hematuria, Current alcohol and/or drug abuse, T1 tumors where re-resection has not been performed, Mental or legal incapatitation or another condition which impair the subjects ability to participate, Participation in another interventional clinical study and treatment with another investigational product 30 days prior to randomization, Pregnancy or breastfeeding, TURB, bladder biopsy or traumatic catheterization with 2 weeks, Previous or current MIBC, Progression, defuned as progression to T1-, T2+ tumour or cystectomy irrespectively of indication or developement of metastatic urothelial cancer irrespectively of tumour stage, Contraindications to BCG, Immune suppressingmedication (cancer therapy e.g. cytostatic medicinal products, radiation, local and systemic steroids e.g. prednisolone is permitted), Incontinence, Need for catheter at the time of instillation, Bilateral nephrostomy catheters; unilateral nephrostomy catherter is allowed IF permanent for the duration of all istillations with BCG AND a normally functioning kidney, Female study subjects of childbearing age: unless they use highly effective methods of contraception from the first BCG instillations untill 14 days after last dose of BCG treatment, difined as total abstinence, female sterilization, oral contraceptives, or intrauterine contraceptive device, Male study subjects; unless they use highly effective methods of contraception from the first BCG instillation until 14 days after the last dose pf BCG treatment, defined as toatl abstinence or use of condoms, Reduced immune response (leukaemia, lymphoma), Known allergy to BCG, Hiv infection if untreated or uncontrolled, Signs of active tuberculosis, Any type of previous radiation therapy involving the bladder, Concomitant invasive cancer within 5 years other than non-melanoma skin cancer and prostate cancer without metastasis, Current urinary tract infection
研究者
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