Clinical trial NCT04687254: Gender-related Characteristics of Bladder Cancer Treatment
Official title: Gender-related Characteristics of Bladder Cancer Treatment. Therapeutic Offer, Pathologic Features and Survival Outcomes of Patients Treated With Radical Cystectomy for Muscle-invasive Bladder Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Radical Cystectomy
Muscle-invasive Bladder Cancer
Lead sponsor: University of Florence
Sponsor class: OTHER
Collaborators: name: marco Carini
name: Sergio Serni
name: Andrea Minervini
name: Pietro Spatafora
name: Giandomenico Roviello
name: Gabriella Nesi
name: Ilaria Camilla Galli
name: Calogero Saieva
name: Graziano Vignolini
name: Giovani Tasso
name: Simone Morselli
First posted: 2020-12-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with radical cystectomy for muscle-invasive bladder cancer

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing radical cystectomy since September 2016 December 2020
* Development of bladder cancer confirmed histologically
* Written informed consent

Exclusion Criteria:

• Lack of clinical and prognostic data on selected patients

Primary outcomes:
measure: gender-related discrepancies in the treatment offer for patients affected by MIBC from September 2016 to December 2020
timeFrame: 36 months
Secondary outcomes:
measure: gender-related difference in the clinical and pathologic features of MIBC
timeFrame: 36 months
measure: gender-related difference in the survival outcomes
timeFrame: 36 months
measure: gender-related difference in the risk factors for development of BC
timeFrame: 36 months
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Donata Villari
state: FI
Study officials:
References: