Bladder CancerNCT06395701
Trimodality Treatment in Bladder Cancer
An observational study of Bladder Cancer and Urinary Bladder Neoplasms, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial summary
Bladder cancer is a malignant disease that affects a large number of people worldwide. An increase in the incidence of this type of cancer has been observed in recent decades, leading to a growing interest in understanding its risk factors, clinical evolution, and possible treatment approaches. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bladder Cancer, Urinary Bladder Neoplasms, Bladder Disease
- What is being tested?
- radioteraphy and chemotherapy after RTU --trimodality therapy--
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2014to 2 Jun 2024
- 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 100 years
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with bladder cancer from 2014 to 2022 and treated with radiotherapy in our Radiation Oncology Service. Demographic data, medical history, risk factors, clinical characteristics, treatments received, and clinical outcomes will be collected
Who may be able to join
- Adult patients (over 18 years old) with histologically confirmed diagnosis of bladder cancer.
- Criteria for selecting optimal candidates for trimodal therapy-assessment in Uro-Oncology committees.
- -Functional and compatible bladder at the start of the study.
- Criteria related to the tumor:
- cT2
- Unifocal tumor with a maximum diameter < 7 cm.
Show all 12Show fewer
- Single tumor.
- Absence of extensive associated carcinoma in situ (CIS).
- Absence of bilateral hydronephrosis.
- Absence of lymphovascular invasion.
- Attempt at macroscopically complete TURBT of the bladder (incomplete does not exclude bladder preservation).
- Availability of complete medical records, including demographic data, medical history, imaging study results, treatment details, and follow-up.
Who cannot join
- Not availability of complete medical records, including demographic data, medical history, imaging study results, treatment details, and follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study Protocol on Bladder Cancer With Bladder Preservation Intent
Bladder cancer is a malignant disease that affects a large number of people worldwide. An increase in the incidence of this type of cancer has been observed in recent decades, leading to a growing interest in understanding its risk factors, clinical evolution, and possible treatment approaches. This retrospective study aims to retrospectively analyze a cohort of patients diagnosed with muscle-invasive bladder cancer, in whom, after presentation at multidisciplinary oncology committees, the goal of curing the oncological disease while preserving the bladder is considered.
Trimodal therapy (TMT) is the most studied bladder preservation strategy, with oncological outcomes superior to those of isolated therapies (or monotherapies) such as transurethral resection of the bladder tumor (TURBT), radiotherapy, or chemotherapy. TMT consists of complete and maximal TURBT of the bladder tumor, followed by definitive radiotherapy combined with a radiosensitizing agent.
Read more
Objectives The main objective is to retrospectively analyze the effectiveness and safety of the trimodal approach in our setting. Collecting and analyzing data from patients treated in our service will provide valuable insight into clinical outcomes and treatment tolerability in this context.
Materials and Methods
- Study Design A retrospective study will be conducted using data from medical records of patients diagnosed with bladder cancer from 2014 to 2022 and treated with radiotherapy in our Radiation Oncology Service. Demographic data, medical history, risk factors, clinical characteristics, treatments received, and clinical outcomes will be collected.
- Study Population The study population will include all patients with confirmed diagnoses of non-metastatic muscle-invasive bladder cancer.
Read the detailed description
- Inclusion Criteria Adult patients (over 18 years old) with histologically confirmed diagnosis of bladder cancer.
Criteria for selecting optimal candidates for trimodal therapy-assessment in Uro-Oncology committees.
-Functional and compatible bladder at the start of the study.
Criteria related to the tumor:
- cT2
- Unifocal tumor with a maximum diameter < 7 cm.
- Single tumor.
- Absence of extensive associated carcinoma in situ (CIS).
- Absence of bilateral hydronephrosis.
- Absence of lymphovascular invasion.
- Attempt at macroscopically complete TURBT of the bladder (incomplete does not exclude bladder preservation).
Availability of complete medical records, including demographic data, medical history, imaging study results, treatment details, and follow-up.
- Data Collection Data will be retrospectively collected from patients' electronic medical records. Standardized forms will be used to record relevant data, including demographic information, medical history, imaging study results, treatment details, and follow-up.
- Statistical Analysis Descriptive analysis of the data will be performed to summarize the characteristics of the study population and clinical outcomes. Appropriate statistical tests will be used to compare patient subgroups and assess the association between variables of interest and clinical outcomes.
- Ethical Considerations This study will be conducted following the ethical principles established in the Helsinki Declaration. Approval will be obtained from our hospital's Ethics Committee.
- Study Limitations Potential limitations of this study may include inherent bias in retrospective studies, incomplete data in some medical records, and variability in treatments administered over time.
- Conditions
- Bladder Cancer, Urinary Bladder Neoplasms, Bladder Disease
- Being tested
- radioteraphy and chemotherapy after RTU --trimodality therapy--
- Medical subject headings
- Urinary Bladder Neoplasms, Urinary Bladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radioteraphy and chemotherapy after RTU --trimodality therapy--Radiation
TMT ( trimodality treatment) consists of complete and maximal TURBT of the bladder tumor, followed by definitive radiotherapy combined with a radiosensitizing agent.
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control
Local Control assessed by RECIST criteria with TC, MRI or PET-scan
Measured: 5-10 years
Secondary outcomes (1)
Overall Survival
Defined as the time from diagnose to the date of death from any cause.
Measured: Overall Survival [ Time Frame: Participants should be followed continuously during 5-10 years Defined as the time from diagnose to the date of death from any cause.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Apr 2014
- Primary completion2 Jun 2024
- Study completion2 Jun 2024
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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Feltes, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395701
- Sponsor's protocol ID
- TRIMODAL-VEJIGA
- Status last verified
- Sep 2024
- First submitted
- 29 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study Protocol on Bladder Cancer With Bladder Preservation Intent
- ClinicalTrials.gov ID
- NCT06395701
- Acronym / sponsor ID
- TRIMODAL-VEJIGA
- Conditions
- Bladder Cancer, Urinary Bladder Neoplasms, Bladder Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 2 Jun 2024 (actual)
- First posted
- 2 May 2024 (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.
Bladder cancer is a malignant disease that affects a large number of people worldwide. An increase in the incidence of this type of cancer has been observed in recent decades, leading to a growing interest in understanding its risk factors, clinical evolution, and possible treatment approaches. This retrospective study aims to retrospectively analyze a cohort of patients diagnosed with muscle-invasive bladder cancer, in whom, after presentation at multidisciplinary oncology committees, the goal of curing the oncological disease while preserving the bladder is considered.
Trimodal therapy (TMT) is the most studied bladder preservation strategy, with oncological outcomes superior to those of isolated therapies (or monotherapies) such as transurethral resection of the bladder tumor (TURBT), radiotherapy, or chemotherapy. TMT consists of complete and maximal TURBT of the bladder tumor, followed by definitive radiotherapy combined with a radiosensitizing agent.
Objectives The main objective is to retrospectively analyze the effectiveness and safety of the trimodal approach in our setting. Collecting and analyzing data from patients treated in our service will provide valuable insight into clinical outcomes and treatment tolerability in this context.
Materials and Methods
- Study Design A retrospective study will be conducted using data from medical records of patients diagnosed with bladder cancer from 2014 to 2022 and treated with radiotherapy in our Radiation Oncology Service. Demographic data, medical history, risk factors, clinical characteristics, treatments received, and clinical outcomes will be collected.
- Study Population The study population will include all patients with confirmed diagnoses of non-metastatic muscle-invasive bladder cancer.
Detailed description
- Inclusion Criteria Adult patients (over 18 years old) with histologically confirmed diagnosis of bladder cancer.
Criteria for selecting optimal candidates for trimodal therapy-assessment in Uro-Oncology committees.
-Functional and compatible bladder at the start of the study.
Criteria related to the tumor:
- cT2
- Unifocal tumor with a maximum diameter < 7 cm.
- Single tumor.
- Absence of extensive associated carcinoma in situ (CIS).
- Absence of bilateral hydronephrosis.
- Absence of lymphovascular invasion.
- Attempt at macroscopically complete TURBT of the bladder (incomplete does not exclude bladder preservation).
Availability of complete medical records, including demographic data, medical history, imaging study results, treatment details, and follow-up.
- Data Collection Data will be retrospectively collected from patients' electronic medical records. Standardized forms will be used to record relevant data, including demographic information, medical history, imaging study results, treatment details, and follow-up.
- Statistical Analysis Descriptive analysis of the data will be performed to summarize the characteristics of the study population and clinical outcomes. Appropriate statistical tests will be used to compare patient subgroups and assess the association between variables of interest and clinical outcomes.
- Ethical Considerations This study will be conducted following the ethical principles established in the Helsinki Declaration. Approval will be obtained from our hospital's Ethics Committee.
- Study Limitations Potential limitations of this study may include inherent bias in retrospective studies, incomplete data in some medical records, and variability in treatments administered over time.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with bladder cancer from 2014 to 2022 and treated with radiotherapy in our Radiation Oncology Service. Demographic data, medical history, risk factors, clinical characteristics, treatments received, and clinical outcomes will be collected
Key inclusion criteria (12 listed)
- Adult patients (over 18 years old) with histologically confirmed diagnosis of bladder cancer.
- Criteria for selecting optimal candidates for trimodal therapy-assessment in Uro-Oncology committees.
- -Functional and compatible bladder at the start of the study.
- cT2
- Unifocal tumor with a maximum diameter < 7 cm.
Key exclusion criteria (1 listed)
- Not availability of complete medical records, including demographic data, medical history, imaging study results, treatment details, and follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radioteraphy and chemotherapy after RTU --trimodality therapy--TMT ( trimodality treatment) consists of complete and maximal TURBT of the bladder tumor, followed by definitive radiotherapy combined with a radiosensitizing agent. | Radiation | – |
Primary outcome
Local Control
Time frame: 5-10 years
Local Control assessed by RECIST criteria with TC, MRI or PET-scan
1 secondary outcome
Overall Survival
Time frame: Overall Survival [ Time Frame: Participants should be followed continuously during 5-10 years Defined as the time from diagnose to the date of death from any cause.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Urinary Bladder Neoplasms, run by Consorci Sanitari de Terrassa at 1 site in Spain.
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 12 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Control (time frame: 5-10 years). 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 19 Sep 2024.