An observational study in Bladder Cancer, Radical Cystectomy and Muscle-invasive Bladder Cancer, sponsored by University of Florence. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-12-29.
Sponsored by University of Florence · Observational
The most frequent cancer of the urinary tract is the bladder cancer (BC), in Italy its incidence reaches the 7% of all the new diagnosis of cancer, accounting for the fifth cause of death in the western countries, overall 140.000 new cases per year in Europe. In the year 2017, the Italian association for medical oncology (AIOM) recorded in our country about 21.700 new diagnosis of BC men and 5.300 in women. This data show not only a relevant gender disparity on the disease incidence (in 5th to 7th decade male incidence: 11-12% of all new diagnosis of cancer versus 1% in women) but also on the outcomes of treatment. Overall, the 30% of all the new diagnosis have a muscle-invasive (MIBC) onset, the female gender suffer a correlation with a more advanced disease at the time of first diagnosis. As a consequence, men have lower BC-related mortality when compared to women (p\<0,001). This discrepancy in the mortality rate has been investigated by many authors, resulting in the evidence that female gender suffers higher risks, especially during the first two-years after the radical cystectomy. A comprehensive explanation has not been formulated yet, but a multiplicity of cofactors, including variations in the hormone receptors and tumor biology as well as the different anatomy between male and female, have been identified as potentially relevant. Another important issue in the pre-operatory management of female patients with BC is the misleading interpretation of hematuria. It seems to directly correlate with the evidence that women suffer a more advanced stage at diagnosis, and this element has been withheld in the list of relevant risk factors for prognosis. Nevertheless, a thorough analysis of their effect will only be possible in the future, as well-designed prospective and randomized clinical trials are currently not available.
A part from the preoperatory disparity, it has also been described that men are more frequently candidates to an orthotopic urinary diversion, leading female patients to an irreversibly altered perception of personal integrity and body image, namely to a lower quality of life after radical cystectomy. The female anatomy has been considered as a limitation to continence recovery, resulting in preoperative counselling more frequently against in favor of ileal conduit or not-continent urinary diversions.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's planned enrollment of 500 is above the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →University of Florence is the lead sponsor of 75 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated with radical cystectomy for muscle-invasive bladder cancer
Exclusion Criteria:
gender-related discrepancies in the treatment offer for patients affected by MIBC from September 2016 to December 2020
Time frame: 36 months
gender-related difference in the clinical and pathologic features of MIBC
Time frame: 36 months
gender-related difference in the survival outcomes
Time frame: 36 months
gender-related difference in the risk factors for development of BC
Time frame: 36 months
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Florence