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Status unknownNCT04687254BladderBLOGUpdated Dec 29, 2020

Gender-related Characteristics of Bladder Cancer Treatment

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 sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
500
Ages
18 Years to 99 Years
Sex
All
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Study 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.

02

Conditions studied

  • Bladder Cancer
  • Radical Cystectomy
  • Muscle-invasive Bladder Cancer
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In context

Urinary Bladder Neoplasms

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated with radical cystectomy for muscle-invasive bladder cancer

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Lack of clinical and prognostic data on selected patients
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. gender-related discrepancies in the treatment offer for patients affected by MIBC from September 2016 to December 2020

    Time frame: 36 months

Secondary outcomes

  1. gender-related difference in the clinical and pathologic features of MIBC

    Time frame: 36 months

  2. gender-related difference in the survival outcomes

    Time frame: 36 months

  3. gender-related difference in the risk factors for development of BC

    Time frame: 36 months

07

Study locations

1 of 1 sites recruiting
  • Donata Villari
    Firenze, FI 50100, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04687254
Lead sponsor
University of Florence
Collaborators
marco Carini, Sergio Serni, Andrea Minervini, Pietro Spatafora, Giandomenico Roviello, Gabriella Nesi, Ilaria Camilla Galli, Calogero Saieva, Graziano Vignolini, Giovani Tasso, Simone Morselli
Responsible party
Donata Villari (Researcher, University of Florence) — Principal investigator
First posted
Dec 29, 2020
Start date
Sep 1, 2020
Primary completion
Apr 2021 (estimated)
Completion
Jun 2021 (estimated)
Last update
Dec 29, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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