MedDataX Logo

Gender-related Characteristics of Bladder Cancer Treatment

NCT ID: NCT04687254

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder Cancer Radical Cystectomy Muscle-invasive Bladder Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

marco Carini

UNKNOWN

Sponsor Role collaborator

Sergio Serni

UNKNOWN

Sponsor Role collaborator

Andrea Minervini

UNKNOWN

Sponsor Role collaborator

Pietro Spatafora

UNKNOWN

Sponsor Role collaborator

Giandomenico Roviello

UNKNOWN

Sponsor Role collaborator

Gabriella Nesi

UNKNOWN

Sponsor Role collaborator

Ilaria Camilla Galli

UNKNOWN

Sponsor Role collaborator

Calogero Saieva

UNKNOWN

Sponsor Role collaborator

Graziano Vignolini

UNKNOWN

Sponsor Role collaborator

Giovani Tasso

UNKNOWN

Sponsor Role collaborator

Simone Morselli

UNKNOWN

Sponsor Role collaborator

University of Florence

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Donata Villari

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Donata Villari

Florence, FI, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Donata Villari, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18094/OSS

Identifier Type: -

Identifier Source: org_study_id