Clinical trial · Interventional
CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood
Circulating Tumor Cell (CTC) Quantification During Transurethral Resection (TURBT) and Plasma Kinetic Vaporisation (PKVBT) of Transitional Cell Carcinoma in Purging Fluid and Blood: a Randomized Controlled Trial
NCT04811846CI-TRIAL-00083471active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 cells (CTCs) have been shown to be a prognostic predictor in disease progression in transitional cell carcinoma. In the current study the investigators aim to quantify CTCs in purging fluid and blood for recurrent intermediate risk bladder cancer during surgery for two different methods: TURBT and Plasma-kinetic vaporization of bladder tumor (PKVBT). Also correlations for recurrence will be investigated for the two different surgical methods.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Circulating Tumor Cell | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Transitional Cell Carcinoma | Transitional Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Urinary Bladder Neoplasm | Bladder Neoplasm | ALIAS | 0.90 |
| Urogenital Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bipolar transurethral plasma kinetic vaporization of bladder tumor (PKVBT) | Device | — | UNRESOLVED |
| Bipolar transurethral resection of bladder tumor (TURBT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- TURBT (Transurethral Resection of Bladder Tumor)
- description
- For patients undergoing bipolar transurethral resection, bladder tumor is resected in a piecemeal manner.
- interventionNames
- Device: Bipolar transurethral resection of bladder tumor (TURBT)
- type
- ACTIVE_COMPARATOR
- label
- PKVB (Plasma Kinetic Vaporization of Bladder Tumor)
- description
- For patients undergoing bipolar plasma kinetic vaporization of bladder tumor, bladder tumor is vaporized.
- interventionNames
- Device: Bipolar transurethral plasma kinetic vaporization of bladder tumor (PKVBT)
Primary outcomes (8)
- measure
- intraoperative CTC-number in blood [n/ml]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (11)
- BACKGROUNDBurger M, Catto JW, Dalbagni G, Grossman HB, Herr H, Karakiewicz P, Kassouf W, Kiemeney LA, La Vecchia C, Shariat S, Lotan Y. Epidemiology and risk factors of urothelial bladder cancer. Eur Urol. 2013 Feb;63(2):234-41. doi: 10.1016/j.eururo.2012.07.033. Epub 2012 Jul 25. PMID 22877502
- BACKGROUNDComperat E, Larre S, Roupret M, Neuzillet Y, Pignot G, Quintens H, Houede N, Roy C, Durand X, Varinot J, Vordos D, Rouanne M, Bakhri MA, Bertrand P, Jeglinschi SC, Cussenot O, Soulie M, Pfister C. Clinicopathological characteristics of urothelial bladder cancer in patients less than 40 years old. Virchows Arch. 2015 May;466(5):589-94. doi: 10.1007/s00428-015-1739-2. Epub 2015 Feb 20. PMID 25697540
- BACKGROUNDSylvester RJ, van der Meijden AP, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, Newling DW, Kurth K. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006 Mar;49(3):466-5; discussion 475-7. doi: 10.1016/j.eururo.2005.12.031. Epub 2006 Jan 17. PMID 16442208
- BACKGROUNDBabjuk M, Bohle A, Burger M, Capoun O, Cohen D, Comperat EM, Hernandez V, Kaasinen E, Palou J, Roupret M, van Rhijn BWG, Shariat SF, Soukup V, Sylvester RJ, Zigeuner R. EAU Guidelines on Non-Muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016. Eur Urol. 2017 Mar;71(3):447-461. doi: 10.1016/j.eururo.2016.05.041. Epub 2016 Jun 17. PMID 27324428
- BACKGROUNDWilby D, Thomas K, Ray E, Chappell B, O'Brien T. Bladder cancer: new TUR techniques. World J Urol. 2009 Jun;27(3):309-12. doi: 10.1007/s00345-009-0398-9. Epub 2009 Mar 4. PMID 19259684
- BACKGROUNDRink M, Schwarzenbach H, Vetterlein MW, Riethdorf S, Soave A. The current role of circulating biomarkers in non-muscle invasive bladder cancer. Transl Androl Urol. 2019 Feb;8(1):61-75. doi: 10.21037/tau.2018.11.05.