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NCT06167057Recruiting

POST URS Chemotherapy Instillation

Single Bladder Instillation With Chemotherapy Following Endoscopic Treatment for Upper Tract Urothelial Carcinoma to Reduce Bladder Recurrence

Source: ClinicalTrials.gov · Last updated 20 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this study is to evaluate the safety and oncological outcomes of single chemotherapy bladder instillation following endoscopic treatment for UTUC in UTUC suspected patients .The main aim is to determine the efficacy of a single, post URS, chemotherapy bladder instillation to reduce IVR. Participants will be given single chemotherapy bladder instillation within 24h following ureteroscopy and will follow routine follow-up for IVR which will include white light cystoscopy ;patients with suspected IVR (based on either imaging or cystoscopy) will undergo TURBT.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
264 (estimated)
First submitted
4 Dec 2023
Start date
17 Apr 2023
Primary completion date
30 Jan 2028
Lead sponsor
Carmel Medical Center
NCT number
NCT06167057

What you commit to

  • Study type: Interventional
  • Planned participants: 264
  • From 17 Apr 2023 to the primary completion date, 30 Jan 2028
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subjects who have had bladder / prostate radiotherapy
  • Subjects with bladder cancer history on active bladder irrigation protocols or with active disease within two years prior to enrollment
  • Subjects with previously treated UTUC within one year prior to enrollment

Other illness

  • Subjects with metastatic disease

Who the study is looking for

  • Radiographic and/or cytological suspicion for UTUC
  • Planned endoscopic procedure for treatment / diagnosis of UTUC
  • Patients with bladder cancer history are eligible if meeting both following criteria:
    • No recurrence within the last two years Are not on active bladder irrigation protocol
  • Patients with history of UTUC are eligible if last endoscopic treatment or RNU was \>1 year prior to enrollment
  • Age ≥ 18 years
  • Performance status ECOG 0-2

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Assuta Ashdod Hospital
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AshdodIsraelRecruiting
Soroka University Medical Center
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BeershebaIsraelRecruiting
Shamir Medical Center
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Be’er Ya‘aqovIsraelRecruiting
Rambam Health Care Campus
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HaifaIsraelRecruiting
Carmel Medical Center
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HaifaIsraelRecruiting
Bnai Zion Medical Center
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HaifaIsraelRecruiting
Rabin Medical Center - Beilinson and Hasharon
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Petah TikvaIsraelRecruiting
Kaplan Medical Center
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RehovotIsraelRecruiting
Ziv Medical Center
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SafedIsraelRecruiting
Tel Aviv Sourasky Medical Center Ichilov
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Tel AvivIsraelRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.