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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04811846

Studienbeginn:
März 2021

Letztes Update:
23.03.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Neoplasms, Neoplastic Cells, Circulating, Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Urogenital Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Teaching Hospital Hall in Tirol

Collaborator:
Salzburger Landeskliniken

Studienleiter

Udo Nagele, MD, Prof.
Study Chair
Head of Department LKH Hall in Tirol
Lukas Lusuardi, MD, Prof.
Study Chair
Heas of Department LKH Salzburg

Kontakt

Studienlocations
(2 von 2)

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

Secondary outcome:

1. Tumor recurrence [yes/no] (Time Frame - According to follow up cystoscopy at 3, 6, 12, 24, 36 months after intervention.):
Tumor recurrence is evaluated between 3 months and 36 months after surgery with follow-up cystoscopy.

2. Time to recurrence [days] (Time Frame - Through study completion, recurrence can occur within a maximum follow up of 36 months.):
The time difference from date of surgery to date of cystoscopic detection of recurrence. Including analysis of influencing factors.

3. preoperative CTC-number in purging fluid [n/ml] (Time Frame - Right before surgery.):
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.

4. preoperative CTC-number in blood [n/ml] (Time Frame - Right before start of surgery.):
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.

5. preoperative CTC morphology in purging fluid (Time Frame - Right before start of 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.

Studien-Arme

  • Active Comparator: TURBT (Transurethral Resection of Bladder Tumor)
    For patients undergoing bipolar transurethral resection, bladder tumor is resected in a piecemeal manner.
  • Active Comparator: PKVB (Plasma Kinetic Vaporization of Bladder Tumor)
    For patients undergoing bipolar plasma kinetic vaporization of bladder tumor, bladder tumor is vaporized.

Geprüfte Regime

  • Bipolar transurethral resection of bladder tumor (TURBT):
    Standard resection in piecemeal technique with standard bipolar cutting loop. (Storz medical, 27040 GP1)
  • Bipolar transurethral plasma kinetic vaporization of bladder tumor (PKVBT):
    Vaporization of bladder tumor with standard bipolar vaporization electrode. (Storz medical, 27040 NB)

Quelle: ClinicalTrials.gov


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