Trained immunity induced by BCG in urothelial carcinoma - Tribute

Radboud Universitair Medisch Centrum0 个研究点目标入组 80 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•1. Presence of high-grade Ta or T1 urothelial carcinoma of the bladder with or without carcinoma in situ; tumor can be primary or recurrent
•2. Able to communicate in Dutch, and read and understand the patient information and informed consent form and fill out questionnaires
•3. Signed and dated informed consent form
•4. Complete resection of (visible) tumor at start of BCG therapy as determined via re-TURT or negative cystoscopy/cytology (at most 6 weeks prior to BCG therapy initiation)

•1. Any previous intravesical BCG therapy
•2. Presence of primary CIS only
•3. Presence of histopathologically proven muscle-invasive urothelial carcinoma of the bladder at first or re-TUR surgical specimens
•4. Presence of tumor stage cN1 of cM1 as assessed by CT-thorax/abdomen
•5. Presence of any upper urinary tract tumors
•6. Histology subtype of resected tumor is not predominant urothelial carcinoma
•7. Presence of another malignancy other than basal cell carcinoma of the skin or prostate cancer under active surveillance
•8. Presence of pregnancy or lactation
•9. Presence of active tuberculosis, any form of immunodeficiency (e.g. HIV + serology, transplant recipients) and/or any other contraindication of BCG therapy
•10. Patients who have received any systemic cytostatic agents within the last 3 months
•11. Patients younger than 18 and older than 85 years of age
•12. Patients with uncontrollable urinary tract infection

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