Precise Chemoresection in Low-grade NMIBC Using Drug Screens in Patient-derived Organoids

Korábbi kezelés

• Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol as judged by the investigator
• Severe infection within 4 weeks prior to the date of the patient's informed consent signature
• Pregnancy or nursing. Female subject of childbearing potential (defined as premenopausal women who have not undergone surgical sterilization and are sexually active with a male part-ner) must have a negative urine pregnancy test at screening
• Concomitant participation in another interventional clinical trial with an active treatment within 4 weeks prior to the date of the patient's informed consent signature and during the current trial.

Egyéb

• Anticoagulation other than acetylsalicylic acid
• Contraindication for frequent catheterization
• Female subject of childbearing potential who is unwilling to use effective contraception method(s) from the start of the intravesical instillation with the IMP until six months after the last instillation
• Male subject who is unwilling to use an effective contraception method from the start of the intravesical instillation with the IMP until four months after the last instillation
• Vulnerable individual, e.g., individual incapable of judgement or currently incarcerated or oth-erwise institutionalized (prisoner), or refugee

• Signed Informed Consent Form
• Age ≥ 18 years
• Primary or recurrent NMIBC suspected to be low-grade or maximum G2 with a negative urine cytology