Brief Title
CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood
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
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 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 Type
Interventional
Primary Outcome
intraoperative CTC-number in blood [n/ml]
Secondary Outcome
Tumor recurrence [yes/no]
Condition
Urinary Bladder Neoplasm
Intervention
Bipolar transurethral resection of bladder tumor (TURBT)
Study Arms / Comparison Groups
TURBT (Transurethral Resection of Bladder Tumor)
Description: For patients undergoing bipolar transurethral resection, bladder tumor is resected in a piecemeal manner.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
40
Start Date
March 14, 2021
Completion Date
August 2025
Primary Completion Date
August 2022
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Udo Nagele, MD, Prof., +43 50 50430, [email protected]
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT04811846
Organization ID
1
Responsible Party
Principal Investigator
Study Sponsor
University Teaching Hospital Hall in Tirol
Collaborators
Salzburger Landeskliniken
Study Sponsor
Udo Nagele, MD, Prof., Study Chair, Head of Department LKH Hall in Tirol
Verification Date
March 2021