Status:
ACTIVE_NOT_RECRUITING
CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood
Lead Sponsor:
University Teaching Hospital Hall in Tirol
Collaborating Sponsors:
Salzburger Landeskliniken
Conditions:
Urinary Bladder Neoplasm
Transitional Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Transurethral resection of bladder tumor (TURBT) is usually performed in a piecemeal technique. Tumor fragmentation and cell spilling could be responsible for high recurrence rates. Circulating tumor ...
Detailed Description
Bladder cancer is the 9th most commonly diagnosed cancer in men worldwide, with a standardized incidence rate of 9.0 per 100,000 person-years for men and 2.2 per 100,000 person-years for women. Amongs...
Eligibility Criteria
Inclusion
- female and male patients
- recurrent bladder tumor
- preoperative cystoscopy
- CT or MRI scan of abdomen not older than 30 days prior to surgery without suspicion of advanced disease (MIBC, metastasis)
- max. non-invasive papillary tumor (pTa) staging in prior histology
- max. low grade grading in prior histology
- max. 5 lesions in actual cystoscopy (all \< 3cm)
- exophytic tumors
- transitional cell cancer of urinary bladder
- patient able to give consent
- signed consent form
Exclusion
- initial tumor
- flat lesion
- \> 3cm
- carcinoma in situ (CIS) in prior histology or suspicious CIS-finding in actual cystoscopy
- high grade grading in prior histology
- ≥ pT1 (tumor infiltration into subepithelial connective tissue) staging in prior histology
- \> 5 lesions
- different entity from transitional cell carcinoma of urinary bladder
- prior radiation
- emergency surgery
- prior indwelling catheter (extraction \< 1 week prior to surgery)
- pregnancy
- orthotopic neobladder
Key Trial Info
Start Date :
March 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04811846
Start Date
March 14 2021
End Date
October 1 2025
Last Update
December 9 2024
Active Locations (2)
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1
LKH Hall in Tirol, Department of Urology and Andrology
Hall in Tirol, Austria, 6060
2
LKH Salzburg, Department of Urology and Andrology
Salzburg, Austria, 5020