Bladder CancerBladderBLOGNCT04687254
Gender-related Characteristics of Bladder Cancer Treatment
An observational study of Bladder Cancer and Radical Cystectomy, run by University of Florence at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bladder Cancer, Radical Cystectomy, Muscle-invasive Bladder Cancer
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2020to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with radical cystectomy for muscle-invasive bladder cancer
Who may be able to join
- Patient undergoing radical cystectomy since September 2016 December 2020
- Development of bladder cancer confirmed histologically
- Written informed consent
Who cannot join
- Lack of clinical and prognostic data on selected patients
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Donata Villari
Florence, FI, 50100
Donata Villari, MD, 3387079707, donata.villari@unifi.it
About this study
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
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.
- Medical subject headings
- Urinary Bladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
gender-related discrepancies in the treatment offer for patients affected by MIBC from September 2016 to December 2020
Measured: 36 months
Secondary outcomes (3)
gender-related difference in the clinical and pathologic features of MIBC
Measured: 36 months
gender-related difference in the survival outcomes
Measured: 36 months
gender-related difference in the risk factors for development of BC
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Sep 2020
- Primary completionApr 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Donata Villari, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687254
- Sponsor's protocol ID
- 18094/OSS
- Acronym
- BladderBLOG
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04687254
- Acronym / sponsor ID
- BladderBLOG / 18094/OSS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- marco Carini, Sergio Serni, Andrea Minervini, Pietro Spatafora, Giandomenico Roviello, Gabriella Nesi, Ilaria Camilla Galli, Calogero Saieva, Graziano Vignolini, Giovani Tasso, Simone Morselli
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with radical cystectomy for muscle-invasive bladder cancer
Key inclusion criteria (3 listed)
- Patient undergoing radical cystectomy since September 2016 December 2020
- Development of bladder cancer confirmed histologically
- Written informed consent
Key exclusion criteria (1 listed)
- Lack of clinical and prognostic data on selected patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
gender-related discrepancies in the treatment offer for patients affected by MIBC from September 2016 to December 2020
Time frame: 36 months
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Radical Cystectomy, run by University of Florence at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gender-related discrepancies in the treatment offer for patients affected by MIBC from September 2016 to December 2020 (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.