Gender-related Characteristics of Bladder Cancer Treatment (BladderBLOG)

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

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.

Study Overview

• Status: Unknown
• Conditions: Bladder Cancer; Muscle-invasive Bladder Cancer; Radical Cystectomy

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Italy
  • FI
    • Firenze, FI, Italy, 50100
      • Recruiting
      • Donata Villari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with radical cystectomy for muscle-invasive bladder cancer

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
gender-related discrepancies in the treatment offer for patients affected by MIBC from September 2016 to December 2020	36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
gender-related difference in the clinical and pathologic features of MIBC	36 months
gender-related difference in the survival outcomes	36 months
gender-related difference in the risk factors for development of BC	36 months

Collaborators and Investigators

• Sponsor: University of Florence
• Collaborators: Giandomenico Roviello; Pietro Spatafora; Graziano Vignolini; Sergio Serni; Gabriella Nesi; marco Carini; Andrea Minervini; Ilaria Camilla Galli; Calogero Saieva; Giovani Tasso; Simone Morselli

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (ACTUAL): December 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 18094/OSS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No