Status:
RECRUITING
POST URS Chemotherapy Instillation
Lead Sponsor:
Carmel Medical Center
Conditions:
UTUC
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 i...
Detailed Description
URS is routinely used for both diagnosis and treatment of UTUC - it is used either as an initial diagnostic procedure or as a curative procedure in cases amenable for endoscopic tumor ablation; either...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Subjects with metastatic disease
Key Trial Info
Start Date :
April 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2028
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT06167057
Start Date
April 17 2023
End Date
January 30 2028
Last Update
December 20 2023
Active Locations (10)
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1
Assuta Ashdod Hospital
Ashdod, Israel
2
Soroka University Medical Center
Beersheba, Israel
3
Shamir Medical Center
Be’er Ya‘aqov, Israel
4
Bnai Zion Medical Center
Haifa, Israel, 31048