Neoplasms Clinical Trial
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
NCT number | NCT04811846 |
Other study ID # | 1 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 14, 2021 |
Est. completion date | August 2025 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | August 2025 |
Est. primary completion date | August 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | LKH Hall in Tirol, Department of Urology and Andrology | Hall In Tirol | |
Austria | LKH Salzburg, Department of Urology and Andrology | Salzburg |
Lead Sponsor | Collaborator |
---|---|
University Teaching Hospital Hall in Tirol | Salzburger Landeskliniken |
Austria,
Babjuk M, Böhle A, Burger M, Capoun O, Cohen D, Compérat EM, Hernández V, Kaasinen E, Palou J, Rouprêt 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. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | During surgery: after evacuation of snippets for TURBT and after full vaporization for PKVBT. | |
Primary | 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. | 2nd postoperative day during morning routine. | |
Primary | 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. | For both gruops (TURBT and PKVB) after insertion of indwelling catheter before finishing surgery. | |
Primary | 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. | After insertion of indwelling catheter before finishing the surgery. | |
Primary | 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. | 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. | |
Primary | 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. | 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. | |
Primary | 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. | 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. | |
Primary | 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. | 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 | Tumor recurrence [yes/no] | Tumor recurrence is evaluated between 3 months and 36 months after surgery with follow-up cystoscopy. | According to follow up cystoscopy at 3, 6, 12, 24, 36 months after intervention. | |
Secondary | Time to recurrence [days] | The time difference from date of surgery to date of cystoscopic detection of recurrence. Including analysis of influencing factors. | Through study completion, recurrence can occur within a maximum follow up of 36 months. | |
Secondary | 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. | Right before surgery. | |
Secondary | 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. | Right before start of surgery. | |
Secondary | 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. | Right before start of surgery. |
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