CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood

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 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

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