NCT04811846Active, not recruiting
CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood
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
Source: ClinicalTrials.gov · Last updated 9 Dec 2024
Brief summary (registry, in English)
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 (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 16 Mar 2021
- Start date
- 14 Mar 2021
- Primary completion date
- 31 May 2025
- Lead sponsor
- University Teaching Hospital Hall in Tirol
- Diseases
- Bladder cancer
- NCT number
- NCT04811846
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 14 Mar 2021 to the primary completion date, 31 May 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- prior radiation
- emergency surgery
- prior indwelling catheter (extraction \< 1 week prior to surgery)
Other
- initial tumor
- flat lesion
- \> 3cm
- \> 5 lesions
- different entity from transitional cell carcinoma of urinary bladder
- pregnancy
- orthotopic neobladder
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| LKH Hall in Tirol, Department of Urology and Andrology Coordinator of this site? Confirm its status | Hall in Tirol | Austria | Unknown status |
| LKH Salzburg, Department of Urology and Andrology Coordinator of this site? Confirm its status | Salzburg | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.