To validate the suggestion that transurethral resection of bladder tumors in patients with suspected muscle invasive bladder cancer can lead to circulating tumor cells.
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
- Bladder and bladder neck disorders (excl calculi)
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of CTCs in 7.5 ml of blood taken from a peripheral vein before vs. after
TURBT. In the second blood tube, CTCs will be isolated to check for metastatic
potential by means of RNA expression.
Secondary outcome
None
Background summary
Patients who suffer from muscle invasive bladder cancer (MIBC) are commonly
treated with radical cystectomy (RC), sometimes in combination with neoadjuvant
chemotherapy (NAC). However, the 5-year survival rate for these patients
remains poor, approximately 50%, and this has not changed during the last
decades. Patients are often diagnosed with metastases within two years after
the initial surgery which suggests that micrometastases might already be
present at the time of surgery. This might be due to the preoperative procedure
used in the diagnosis of MIBC patients, namely transurethral resection of the
bladder tumor (TURBT). During TURBT the bladder is rinsed with a fluid under
high pressure while it is attempted to remove the tumor completely. This is
quite exceptional in the management of cancer. In other cancer types, the
diagnosis is only made by a biopsy plus imaging before radical treatment. The
TURBT procedure was found to be capable of damaging the bladder wall, and blood
and lymphatic vessels, which might push the tumor cells into the circulation
leading to the formation of micrometastases. Furthermore, the pressure induced
in the bladder during TURBT is higher than the venous pressure in the
surrounding blood vessels, which supports the possibility of the tumor cells
being pushed out of the bladder into the blood stream during this procedure.
These factors, together with the complexity of removing the entire tumor that
invades the bladder wall, might lead to an increased risk of developing
metastases. Previous small-scale research has suggested that the level of
circulating tumor cells (CTCs) in the blood may increase after TURBT which may
result in the formation of micrometastases and as a consequence early disease
recurrence. Furthermore, meta-analysis results showed that MIBC patients with
CTCs had a worse prognosis compared to patients with no CTCs.
Study objective
To validate the suggestion that transurethral resection of bladder tumors in
patients with suspected muscle invasive bladder cancer can lead to circulating
tumor cells.
Study design
Patients who are cystoscopically suspected for muscle invasive bladder cancer
will be asked to consent with a blood draw just prior and just after the TURBT.
The blood samples are transported at room temperature within 24 hours to the
Radboudumc, processed, and tumor cells are counted with the Parsortix system.
Study burden and risks
Negligible
Geert Grooteplein Noord 21
Nijmegen 6525 EZ
NL
Geert Grooteplein Noord 21
Nijmegen 6525 EZ
NL
Listed location countries
Age
Inclusion criteria
Patients suspected of muscle invasive bladder cancer, planned for transurethral
resection for local staging
Exclusion criteria
Not capable of giving informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL76997.091.21 |