Urinary Bladder NeoplasmNCT04811846
CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood
A study testing Bipolar transurethral resection of bladder tumor (TURBT) and Bipolar transurethral plasma kinetic vaporization of bladder tumor (PKVBT) in people with Urinary Bladder Neoplasm and Transitional Cell Carcinoma, run by University Teaching Hospital Hall in Tirol at 2 sites in Austria.
Trial 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 cells (CTCs) have been shown to be a prognostic predictor in disease progression in transitional cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasm, Transitional Cell Carcinoma, Urogenital Neoplasms
- What is being tested?
- Bipolar transurethral resection of bladder tumor (TURBT) and Bipolar transurethral plasma kinetic vaporization of bladder tumor (PKVBT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesAustria
- Study dates
- 14 Mar 2021to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- max. 5 lesions in actual cystoscopy (all < 3cm)
- exophytic tumors
- transitional cell cancer of urinary bladder
- patient able to give consent
- signed consent form
Who cannot join
- 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
Show all 13Show fewer
- > 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
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
LKH Hall in Tirol, Department of Urology and Andrology
Hall in Tirol, 6060
LKH Salzburg, Department of Urology and Andrology
Salzburg, 5020
About this study
Official title: 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
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.
Read the 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. Amongst any caner entity, bladder cancer is the most expensive cancer regarding follow-up and life-time treatment costs due to the high probability of recurrence. Up to 85% of patients initially present with non muscle-invasive bladder cancer (NMIBC). Progression to muscle-invasive bladder cancer (MIBC) is up to 10-20%. NMIBC is characterized by a high risk of recurrence after transurethral resection of bladder tumor (TURBT): the 1-yr recurrence rate is 15-61% and the 5-yr recurrence rate is 31-78%. These numbers represent the heterogeneity of NMIBC.
Against any existing oncological principle, during TURBT bladder tumors are resected in a piecemeal manner. This results in tumor fragmentation and floating cancer cells inside the bladder during surgery. These cells may have the ability to re-attach on and re-implant into the bladder wall and may be responsible for early disease recurrence which is commonly seen after initial surgery. It has been shown that tumor cells may access the circulatory system through cut vessels. Circulating tumor cells (CTCs) can be detected in up to 20% in T1 high grade disease and are commonly seen in metastasized disease. They have shown to be an independent predictor of disease progression and relapse in several studies and reflect biological aggressiveness.
In the current study the investigators want to quantify CTCs for recurrent intermediate risk transitional cell carcinoma in purging fluid and blood for two different surgical methods: TURBT and Plasma-kinetic vaporisation of bladder tumors (PKVBT). Also correlations for recurrence will be investigated for the two different surgical methods.
In 2 urological centers (LKH Hall, LKH Salzburg) participants with diagnosed intermediate risk recurrent transitional cell carcinoma of the bladder will be randomly enrolled for either TURBT or PKVBT. Before surgery CTCs will be analyzed in peripheral blood and purging fluid. (preoperative CTCs blood and purging fluid, morphological aspect of CTCs in purging fluid) After resection for TURBT and vaporization for PKVBT, a tumor ground biopsy will be taken for both groups. After coagluation, CTCs will again be drawn in peripheral blood (intraoperative CTCs blood). After completion of surgery an indwelling catheter is inserted and purging fluid is again analyzed (postoperative CTCs purging fluid, morphological aspect of CTCs in purging fluid). Blood is again taken on day 2 after surgery during the morning routine to assess CTCs after surgery (postoperative CTCs blood). Patients will be dismissed on earliest day 2 after surgery after indwelling catheter removal.
Recurrence will be assessed during follow-up by cystoscopic controls (From 3 to 36 months after surgery). If recurrence is detected the study is terminated. If no recurrence is detected up to 36 months after surgery, the study is likewise terminated.
- Conditions
- Urinary Bladder Neoplasm, Transitional Cell Carcinoma, Urogenital Neoplasms, Circulating Tumor Cell, Neoplasms
- Being tested
- Bipolar transurethral resection of bladder tumor (TURBT), Bipolar transurethral plasma kinetic vaporization of bladder tumor (PKVBT)
- Keywords
- Bladder cancer, NMIBC, CTC, Circulating tumor cell, Transurethral resection, Plasma kinetic vaporization, TURBT, PKVB
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Urogenital Neoplasms, Neoplastic Cells, Circulating, Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar transurethral resection of bladder tumor (TURBT)Device
Standard resection in piecemeal technique with standard bipolar cutting loop. (Storz medical, 27040 GP1)
Bipolar transurethral plasma kinetic vaporization of bladder tumor (PKVBT)Device
Vaporization of bladder tumor with standard bipolar vaporization electrode. (Storz medical, 27040 NB)
| Study group | Role | What they receive |
|---|---|---|
| TURBT (Transurethral Resection of Bladder Tumor) | Active comparator | For patients undergoing bipolar transurethral resection, bladder tumor is resected in a piecemeal manner. Receives: Device: Bipolar transurethral resection of bladder tumor (TURBT) |
| PKVB (Plasma Kinetic Vaporization of Bladder Tumor) | Active comparator | For patients undergoing bipolar plasma kinetic vaporization of bladder tumor, bladder tumor is vaporized. Receives: Device: Bipolar transurethral plasma kinetic vaporization of bladder tumor (PKVBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative CTC-number in blood [n/ml]
Circulating tumor cells (CTCs) are measured in 15ml of peripheral blood which is taken during surgery. CTCs are quantified via automated immunofluorescence-microscopy. CK20+, p53+, DAPI+ and CD45- cells will be classified transitional cancer CTCs.
Measured: During surgery: after evacuation of snippets for TURBT and after full vaporization for PKVBT.
postoperative CTC-number in blood [n/ml]
Circulating tumor cells (CTCs) are measured in 15ml peripheral blood which is taken after surgery. CTCs are quantified via automated immunofluorescence-microscopy. CK20+, p53+, DAPI+ and CD45- cells will be classified transitional cancer CTCs.
Measured: 2nd postoperative day during morning routine.
postoperative CTC-number in purging fluid [n/ml]
Circulating tumor cells (CTCs) are measured in purging fluid after the surgical intervention. After insertion of a new indwelling catheter the bladder is fully emptied and 100ml of sterile NaCl 0,9% is injected and extracted 5 times into and out of the bladder to mix CTCs. CTCs are quantified via automated immunofluorescence-microscopy. CK20+, p53+, DAPI+ and CD45- cells will be classified transitional cancer CTCs.
Measured: For both gruops (TURBT and PKVB) after insertion of indwelling catheter before finishing surgery.
postoperative CTC morphology in purging fluid
Cytological morphology of CTCs in purging fluid. CTCs will be examined for both groups and their morphological aspect (e.g. vital, non-vital, necrotic, deformed) is classified.
Measured: After insertion of indwelling catheter before finishing the surgery.
pre-to-intraoperative change of CTC-number in blood [n/ml]
The difference of the preoperative and intraoperative CTC-number in blood is calculated. Due to the intervention in both groups a difference in CTC-number is to be expected.
Measured: Preoperative CTCs will be taken right before the start of surgery. Intraoperative CTCs will be taken after evacuation of snippets for TURBT and after full vaporization for PKVBT.
pre-to-postoperative change of CTC-number in blood [n/ml]
The difference of the preoperative and postoperative CTC-number in blood is calculated. Due to the intervention in both groups a difference in CTC-number is to be expected.
Measured: Preoperative CTCs will be taken right before the start of surgery. Postoperative CTCs will be taken on day 2 after surgery during the morning routine.
intra-to-postoperative change of CTC-number in blood [n/ml]
The difference of the intraoperative and postoperative CTC-number in blood is calculated. Due to the intervention in both groups a difference in CTC-number is to be expected.
Measured: Intraoperative CTCs will be taken after evacuation of snippets for TURBT and after full vaporization for PKVBT. Postoperative CTCs will be taken on day 2 after surgery during the morning routine.
pre-to-postoperative change of CTC-number in purging fluid [n/ml]
The difference of the preoperative and postoperative CTC-number in purging fluid is calculated. Due to the intervention in both groups a difference in CTC-number is to be expected.
Measured: Preoperative CTCs in purging fluid are taken via an indwelling catheter right before start of the surgery. Postoperative CTCs in purging fluid are taken after insertion of a new indwelling catheter before finishing the surgery.
Secondary outcomes (5)
Tumor recurrence [yes/no]
Tumor recurrence is evaluated between 3 months and 36 months after surgery with follow-up cystoscopy.
Measured: According to follow up cystoscopy at 3, 6, 12, 24, 36 months after intervention.
Time to recurrence [days]
The time difference from date of surgery to date of cystoscopic detection of recurrence. Including analysis of influencing factors.
Measured: Through study completion, recurrence can occur within a maximum follow up of 36 months.
preoperative CTC-number in purging fluid [n/ml]
Circulating tumor cells (CTCs) are measured in purging fluid before the surgical intervention. After insertion of an indwelling catheter the bladder is fully emptied and 100ml of sterile NaCl 0,9% is injected and extracted 5 times into and out of the bladder to mix CTCs. CTCs are quantified via automated immunofluorescence-microscopy. CK20+, p53+, DAPI+ and CD45- cells will be classified transitional cancer CTCs.
Measured: Right before surgery.
preoperative CTC-number in blood [n/ml]
Circulating tumor cells (CTCs) are measured in 15ml peripheral blood which is taken right before surgery. CTCs are quantified via automated immunofluorescence-microscopy. CK20+, p53+, DAPI+ and CD45- cells will be classified transitional cancer CTCs.
Measured: Right before start of surgery.
preoperative CTC morphology in purging fluid
Cytological morphology of CTCs in purging fluid. CTCs will be examined for both groups and their morphological aspect (e.g. vital, non-vital, necrotic, deformed) is classified.
Measured: Right before start of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start14 Mar 2021
- Primary completion31 May 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot trial with parallel group design and comparison of 2 established techniques (TURBT, PKVB)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Teaching Hospital Hall in Tirol
- Sponsor type
- University, hospital or other
- Collaborators
- Salzburger Landeskliniken
- Responsible party
- Principal investigator, Gernot Ortner, University Teaching Hospital Hall in Tirol
- Investigators
- Udo Nagele, MD, Prof., Study chair, Head of Department LKH Hall in TirolLukas Lusuardi, MD, Prof., Study chair, Heas of Department LKH Salzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811846
- Sponsor's protocol ID
- 1
- Status last verified
- Dec 2024
- First submitted
- 16 Mar 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burger 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.
PubMed 22877502Comperat 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.
PubMed 25697540Sylvester 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.
PubMed 16442208Babjuk 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.
PubMed 27324428Wilby 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.
PubMed 19259684Rink 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.
PubMed 30976570Engilbertsson H, Aaltonen KE, Bjornsson S, Kristmundsson T, Patschan O, Ryden L, Gudjonsson S. Transurethral bladder tumor resection can cause seeding of cancer cells into the bloodstream. J Urol. 2015 Jan;193(1):53-7. doi: 10.1016/j.juro.2014.06.083. Epub 2014 Jul 1.
PubMed 24996129Zare R, Grabe M, Hermann GG, Malmstrom PU. Can routine outpatient follow-up of patients with bladder cancer be improved? A multicenter prospective observational assessment of blue light flexible cystoscopy and fulguration. Res Rep Urol. 2018 Oct 9;10:151-157. doi: 10.2147/RRU.S141314. eCollection 2018.
PubMed 30349812Donat SM, North A, Dalbagni G, Herr HW. Efficacy of office fulguration for recurrent low grade papillary bladder tumors less than 0.5 cm. J Urol. 2004 Feb;171(2 Pt 1):636-9. doi: 10.1097/01.ju.0000103100.22951.5e.
PubMed 14713776Gazzaniga P, de Berardinis E, Raimondi C, Gradilone A, Busetto GM, De Falco E, Nicolazzo C, Giovannone R, Gentile V, Cortesi E, Pantel K. Circulating tumor cells detection has independent prognostic impact in high-risk non-muscle invasive bladder cancer. Int J Cancer. 2014 Oct 15;135(8):1978-82. doi: 10.1002/ijc.28830. Epub 2014 Mar 13.
PubMed 24599551Sievert KD, Amend B, Nagele U, Schilling D, Bedke J, Horstmann M, Hennenlotter J, Kruck S, Stenzl A. Economic aspects of bladder cancer: what are the benefits and costs? World J Urol. 2009 Jun;27(3):295-300. doi: 10.1007/s00345-009-0395-z. Epub 2009 Mar 7.
PubMed 19271220
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04811846
- Acronym / sponsor ID
- 1
- Conditions
- Urinary Bladder Neoplasm, Transitional Cell Carcinoma, Urogenital Neoplasms, Circulating Tumor Cell, Neoplasms
- Keywords
- Bladder cancer, NMIBC, CTC, Circulating tumor cell, Transurethral resection, Plasma kinetic vaporization, TURBT, PKVB
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Teaching Hospital Hall in TirolUniversity, hospital or other
- Collaborators
- Salzburger Landeskliniken
- Study start
- 14 Mar 2021 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. Amongst any caner entity, bladder cancer is the most expensive cancer regarding follow-up and life-time treatment costs due to the high probability of recurrence. Up to 85% of patients initially present with non muscle-invasive bladder cancer (NMIBC). Progression to muscle-invasive bladder cancer (MIBC) is up to 10-20%. NMIBC is characterized by a high risk of recurrence after transurethral resection of bladder tumor (TURBT): the 1-yr recurrence rate is 15-61% and the 5-yr recurrence rate is 31-78%. These numbers represent the heterogeneity of NMIBC.
Against any existing oncological principle, during TURBT bladder tumors are resected in a piecemeal manner. This results in tumor fragmentation and floating cancer cells inside the bladder during surgery. These cells may have the ability to re-attach on and re-implant into the bladder wall and may be responsible for early disease recurrence which is commonly seen after initial surgery. It has been shown that tumor cells may access the circulatory system through cut vessels. Circulating tumor cells (CTCs) can be detected in up to 20% in T1 high grade disease and are commonly seen in metastasized disease. They have shown to be an independent predictor of disease progression and relapse in several studies and reflect biological aggressiveness.
In the current study the investigators want to quantify CTCs for recurrent intermediate risk transitional cell carcinoma in purging fluid and blood for two different surgical methods: TURBT and Plasma-kinetic vaporisation of bladder tumors (PKVBT). Also correlations for recurrence will be investigated for the two different surgical methods.
In 2 urological centers (LKH Hall, LKH Salzburg) participants with diagnosed intermediate risk recurrent transitional cell carcinoma of the bladder will be randomly enrolled for either TURBT or PKVBT. Before surgery CTCs will be analyzed in peripheral blood and purging fluid. (preoperative CTCs blood and purging fluid, morphological aspect of CTCs in purging fluid) After resection for TURBT and vaporization for PKVBT, a tumor ground biopsy will be taken for both groups. After coagluation, CTCs will again be drawn in peripheral blood (intraoperative CTCs blood). After completion of surgery an indwelling catheter is inserted and purging fluid is again analyzed (postoperative CTCs purging fluid, morphological aspect of CTCs in purging fluid). Blood is again taken on day 2 after surgery during the morning routine to assess CTCs after surgery (postoperative CTCs blood). Patients will be dismissed on earliest day 2 after surgery after indwelling catheter removal.
Recurrence will be assessed during follow-up by cystoscopic controls (From 3 to 36 months after surgery). If recurrence is detected the study is terminated. If no recurrence is detected up to 36 months after surgery, the study is likewise terminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot trial with parallel group design and comparison of 2 established techniques (TURBT, PKVB)
| Arm | Type | Receives |
|---|---|---|
| TURBT (Transurethral Resection of Bladder Tumor) | Active comparator | Device: Bipolar transurethral resection of bladder tumor (TURBT)For patients undergoing bipolar transurethral resection, bladder tumor is resected in a piecemeal manner. |
| PKVB (Plasma Kinetic Vaporization of Bladder Tumor) | Active comparator | Device: Bipolar transurethral plasma kinetic vaporization of bladder tumor (PKVBT)For patients undergoing bipolar plasma kinetic vaporization of bladder tumor, bladder tumor is vaporized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bipolar transurethral resection of bladder tumor (TURBT)Standard resection in piecemeal technique with standard bipolar cutting loop. (Storz medical, 27040 GP1) | Device | TURBT (Transurethral Resection of Bladder Tumor) |
| Bipolar transurethral plasma kinetic vaporization of bladder tumor (PKVBT)Vaporization of bladder tumor with standard bipolar vaporization electrode. (Storz medical, 27040 NB) | Device | PKVB (Plasma Kinetic Vaporization of Bladder Tumor) |
Primary outcome
intraoperative CTC-number in blood [n/ml]
Time frame: During surgery: after evacuation of snippets for TURBT and after full vaporization for PKVBT.
Circulating tumor cells (CTCs) are measured in 15ml of peripheral blood which is taken during surgery. CTCs are quantified via automated immunofluorescence-microscopy. CK20+, p53+, DAPI+ and CD45- cells will be classified transitional cancer CTCs.
postoperative CTC-number in blood [n/ml]
Time frame: 2nd postoperative day during morning routine.
Circulating tumor cells (CTCs) are measured in 15ml peripheral blood which is taken after surgery. CTCs are quantified via automated immunofluorescence-microscopy. CK20+, p53+, DAPI+ and CD45- cells will be classified transitional cancer CTCs.
postoperative CTC-number in purging fluid [n/ml]
Time frame: For both gruops (TURBT and PKVB) after insertion of indwelling catheter before finishing surgery.
Circulating tumor cells (CTCs) are measured in purging fluid after the surgical intervention. After insertion of a new indwelling catheter the bladder is fully emptied and 100ml of sterile NaCl 0,9% is injected and extracted 5 times into and out of the bladder to mix CTCs. CTCs are quantified via automated immunofluorescence-microscopy. CK20+, p53+, DAPI+ and CD45- cells will be classified transitional cancer CTCs.
postoperative CTC morphology in purging fluid
Time frame: After insertion of indwelling catheter before finishing the surgery.
Cytological morphology of CTCs in purging fluid. CTCs will be examined for both groups and their morphological aspect (e.g. vital, non-vital, necrotic, deformed) is classified.
pre-to-intraoperative change of CTC-number in blood [n/ml]
Time frame: Preoperative CTCs will be taken right before the start of surgery. Intraoperative CTCs will be taken after evacuation of snippets for TURBT and after full vaporization for PKVBT.
The difference of the preoperative and intraoperative CTC-number in blood is calculated. Due to the intervention in both groups a difference in CTC-number is to be expected.
pre-to-postoperative change of CTC-number in blood [n/ml]
Time frame: Preoperative CTCs will be taken right before the start of surgery. Postoperative CTCs will be taken on day 2 after surgery during the morning routine.
The difference of the preoperative and postoperative CTC-number in blood is calculated. Due to the intervention in both groups a difference in CTC-number is to be expected.
intra-to-postoperative change of CTC-number in blood [n/ml]
Time frame: Intraoperative CTCs will be taken after evacuation of snippets for TURBT and after full vaporization for PKVBT. Postoperative CTCs will be taken on day 2 after surgery during the morning routine.
The difference of the intraoperative and postoperative CTC-number in blood is calculated. Due to the intervention in both groups a difference in CTC-number is to be expected.
pre-to-postoperative change of CTC-number in purging fluid [n/ml]
Time frame: Preoperative CTCs in purging fluid are taken via an indwelling catheter right before start of the surgery. Postoperative CTCs in purging fluid are taken after insertion of a new indwelling catheter before finishing the surgery.
The difference of the preoperative and postoperative CTC-number in purging fluid is calculated. Due to the intervention in both groups a difference in CTC-number is to be expected.
5 secondary outcomes
Tumor recurrence [yes/no]
Time frame: According to follow up cystoscopy at 3, 6, 12, 24, 36 months after intervention.
Time to recurrence [days]
Time frame: Through study completion, recurrence can occur within a maximum follow up of 36 months.
preoperative CTC-number in purging fluid [n/ml]
Time frame: Right before surgery.
preoperative CTC-number in blood [n/ml]
Time frame: Right before start of surgery.
preoperative CTC morphology in purging fluid
Time frame: Right before start of surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Background: PubMed 22877502Burger 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.
- Background: PubMed 25697540Comperat 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.
- Background: PubMed 16442208Sylvester 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Udo Nagele, MD, Prof. study chair
Head of Department LKH Hall in Tirol
Lukas Lusuardi, MD, Prof. study chair
Heas of Department LKH Salzburg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar transurethral resection of bladder tumor (TURBT) and Bipolar transurethral plasma kinetic vaporization of bladder tumor (PKVBT) in people with Urinary Bladder Neoplasm and Transitional Cell Carcinoma, run by University Teaching Hospital Hall in Tirol at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative CTC-number in blood [n/ml] (time frame: During surgery: after evacuation of snippets for TURBT and after full vaporization for PKVBT.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04811846, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.