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Prospective randomised study of the impact of preoperative administration of mitomycin-C by electromotive drug administration (EMDA) in patients with non-muscle invasive urothelial carcinoma
EU CTIS ID: 2024-510867-42-00
What this study is testing
Determine the impact of electromotive drug administration (EMDA) with mitomycin C (MMC) before transurethral resection (TUR) in patients with primary and recurrent low-grade non-muscle invasive bladder tumors and evaluate the recurrence rate (understanding recurrence as the appearance of a new non-muscle invasive bladder tumor with staging T grade equal to or lower than the baseline tumor) and/or progression (understanding progression as the appearance of a new bladder tumor with staging T grade higher than the baseline tumor) and the time to first event in patients with NMIBC who receive MMC+EMDA before TUR compared to passive diffusion MMC instillation after TUR.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with suspected urothelial cell carcinoma Ta or T1 based on cystoscopy and/or ultrasound.
- Primary papillary tumor
- Recurrent low-grade single or multiple tumors.
- Patients with preserved renal function (serum creatinine < 1.12 mg/dl) and normal liver function (gamma-glutamyl transpeptidase ≤ 51 U/L, alanine aminotransferase ≤ 50 U/L, and total bilirubin ≤ 22 μmol/L).
- Documented and signed authorization to participate in clinica trial
You likely can't join if
- Patients with histology different from urothelial carcinoma after the pathological analysis of the surgical specimen.
- History of untreated urinary tract infection.
- Severe systemic infection.
- Treatment with radiotherapy or chemotherapy.
- Treatment with immunosuppressants.
- Patients with a pacemaker or implantable cardioverter-defibrillator (ICD).
See the full eligibility criteria
- Patients with suspected urothelial cell carcinoma Ta or T1 based on cystoscopy and/or ultrasound.
- Primary papillary tumor
- Recurrent low-grade single or multiple tumors.
- Patients with preserved renal function (serum creatinine < 1.12 mg/dl) and normal liver function (gamma-glutamyl transpeptidase ≤ 51 U/L, alanine aminotransferase ≤ 50 U/L, and total bilirubin ≤ 22 μmol/L).
- Documented and signed authorization to participate in clinica trial
- Patients with histology different from urothelial carcinoma after the pathological analysis of the surgical specimen.
- History of untreated urinary tract infection.
- Severe systemic infection.
- Treatment with radiotherapy or chemotherapy.
- Treatment with immunosuppressants.
- Patients with a pacemaker or implantable cardioverter-defibrillator (ICD).
- Other malignancies within the 5 years prior to study inclusion (except for effectively treated skin cancer or localized cervical cancer).
- Pregnancy.
- Patients with bladder cancer staged ≥ T2.
- Patients with synchronous upper tract urothelial carcinoma (UTUC)
- Allergy to Mitomycin-C.
- Patients who, in the investigator's opinion, are unable to complete the study questionnaires or attend follow-up visits.
- Patients with recurrent high-grade tumor.
- Patients with recurrent CIS.
- Reduced bladder capacity (less than 200 cc)
- History of high-grade bladder tumor or CIS.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.