Bladder CancerIATREP_NMIBCNCT07798479
Age and Bladder Cancer Outcomes After BCG Treatment: A Multicenter Study
An observational study of Bladder Cancer and NMIBC, run by Insel Gruppe AG, University Hospital Bern.
Trial summary
This study investigates whether a patient's age affects the outcomes of Bacillus Calmette-Guérin (BCG) treatment for high-grade bladder cancer. Bladder cancer is a common cancer that can sometimes grow into the deeper layers of the bladder wall. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, NMIBC
- What is being tested?
- Intravesical Bcg
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2009to 31 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients with primary pT1 high-grade urothelial bladder cancer who underwent transurethral resection of the bladder tumor, followed by repeat resection confirming no residual tumor, and subsequently received intravesical BCG therapy according to current EAU guidelines. The retrospective multicenter cohort includes 64 patients. Patients are evaluated according to age, with comparisons using age thresholds of 70 and 75 years. The study population includes both male and female patients and represents patients treated with standard-of-care BCG therapy in routine clinical practice.
Who may be able to join
- Treatment: TUR-B + Re-TUR-B + BCG (≥6 instillations)
Who cannot join
- Re-TUR-B > 56 after TUR-B
- Residual tumor on re-TUR-B histology
- non-urothelial histology
About this study
Official title: Impact of Age on Oncologic Outcomes After BCG Therapy in Primary pT1 High-Grade Bladder Cancer: A Retrospective Multicenter Cohort Study
This study investigates whether a patient's age affects the outcomes of Bacillus Calmette-Guérin (BCG) treatment for high-grade bladder cancer.
Bladder cancer is a common cancer that can sometimes grow into the deeper layers of the bladder wall. In this study, we focus on patients with primary pT1 high-grade bladder cancer, a form of bladder cancer with a higher risk of coming back or progressing. Standard treatment includes removal of the tumor through the urethra (transurethral resection), a second procedure to check that no tumor remains, and treatment with BCG, which is given directly into the bladder to reduce the risk of the cancer returning or progressing.
Read more
Current treatment recommendations do not change BCG treatment based on a patient's age. However, some previous studies have suggested that BCG may be less effective in older patients. Because the number of older adults with bladder cancer is increasing, it is important to understand whether age should influence treatment decisions.
This is a retrospective multicenter cohort study. Researchers will review medical records of patients with primary pT1 high-grade bladder cancer who underwent transurethral resection, repeat resection showing no remaining tumor, and BCG treatment according to current European Association of Urology (EAU) recommendations. The study will compare cancer outcomes between different age groups.
The main outcomes of interest are:
Recurrence-free survival: how long patients remain free from a return of bladder cancer.
Progression-free survival: how long patients remain free from worsening or more advanced bladder cancer.
Overall survival: how long patients remain alive after treatment.
The study includes 64 patients, with a median follow-up period of 43 months. Patients were compared using age thresholds of 70 and 75 years. The results showed no significant difference in the risk of cancer recurrence or progression between younger and older patients based on these age thresholds.
Other tumor and patient characteristics may influence outcomes. In this study, carcinoma in situ and very high-risk tumors were associated with a higher risk of progression in some analyses, while female sex was associated with a higher risk of recurrence and progression in multivariable analyses.
Overall, the findings suggest that age alone may not be associated with worse cancer outcomes after BCG treatment for primary pT1 high-grade bladder cancer. Therefore, older age by itself should not necessarily be a reason to withhold BCG treatment. Treatment decisions should be individualized and take into account the patient's overall health, tumor characteristics, treatment tolerance, and preferences.
This study is retrospective, meaning that researchers analyze information that has already been collected during routine medical care. It does not assign patients to different treatments.
- Conditions
- Bladder Cancer, NMIBC
- Being tested
- Intravesical Bcg
- Keywords
- bladder cancer, NMIBC, BCG therapy, age, immunosenescence, recurrence, progression
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Recurrence, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravesical BcgDrug
This is a retrospective observational study with no assigned study intervention. Patients received standard-of-care Bacillus Calmette-Guérin (BCG) therapy for primary pT1 high-grade bladder cancer as part of routine clinical care, following transurethral resection and repeat resection confirming no residual tumor. BCG was administered intravesically according to current European Association of Urology (EAU) recommendations. The study does not compare different BCG preparations, doses, or treatment schedules. Instead, it evaluates whether patient age is associated with recurrence-free survival, progression-free survival, and overall survival after standard BCG treatment. No experimental treatment or change in clinical management is performed as part of the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
Time from initial transurethral resection to first documented bladder cancer recurrence or last follow-up.
Measured: From date of initial transurethral resection (Day 1) until first documented recurrence or last follow-up, assessed retrospectively up to 69 months.
Secondary outcomes (2)
Progression-free survival
Time from initial transurethral resection to first documented disease progression, death from any cause, or last follow-up.
Measured: From date of initial transurethral resection (Day 1) until first documented disease progression or last follow-up, assessed retrospectively up to 69 months.
Overall survival
Time from initial transurethral resection to death from any cause or last follow-up.
Measured: From date of initial transurethral resection (Day 1) until death from any cause or last follow-up, assessed retrospectively up to 69 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Mar 2009
- Primary completion31 May 2024
- Study completion31 May 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.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798479
- Sponsor's protocol ID
- 6096
- Acronym
- IATREP_NMIBC
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Age on Oncologic Outcomes After BCG Therapy in Primary pT1 High-Grade Bladder Cancer: A Retrospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07798479
- Acronym / sponsor ID
- IATREP_NMIBC / 6096
- Conditions
- Bladder Cancer, NMIBC
- Keywords
- bladder cancer, NMIBC, BCG therapy, age, immunosenescence, recurrence, progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Mar 2009 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 1 Sep 2026 (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.
This study investigates whether a patient's age affects the outcomes of Bacillus Calmette-Guérin (BCG) treatment for high-grade bladder cancer.
Bladder cancer is a common cancer that can sometimes grow into the deeper layers of the bladder wall. In this study, we focus on patients with primary pT1 high-grade bladder cancer, a form of bladder cancer with a higher risk of coming back or progressing. Standard treatment includes removal of the tumor through the urethra (transurethral resection), a second procedure to check that no tumor remains, and treatment with BCG, which is given directly into the bladder to reduce the risk of the cancer returning or progressing.
Current treatment recommendations do not change BCG treatment based on a patient's age. However, some previous studies have suggested that BCG may be less effective in older patients. Because the number of older adults with bladder cancer is increasing, it is important to understand whether age should influence treatment decisions.
This is a retrospective multicenter cohort study. Researchers will review medical records of patients with primary pT1 high-grade bladder cancer who underwent transurethral resection, repeat resection showing no remaining tumor, and BCG treatment according to current European Association of Urology (EAU) recommendations. The study will compare cancer outcomes between different age groups.
The main outcomes of interest are:
Recurrence-free survival: how long patients remain free from a return of bladder cancer.
Progression-free survival: how long patients remain free from worsening or more advanced bladder cancer.
Overall survival: how long patients remain alive after treatment.
The study includes 64 patients, with a median follow-up period of 43 months. Patients were compared using age thresholds of 70 and 75 years. The results showed no significant difference in the risk of cancer recurrence or progression between younger and older patients based on these age thresholds.
Other tumor and patient characteristics may influence outcomes. In this study, carcinoma in situ and very high-risk tumors were associated with a higher risk of progression in some analyses, while female sex was associated with a higher risk of recurrence and progression in multivariable analyses.
Overall, the findings suggest that age alone may not be associated with worse cancer outcomes after BCG treatment for primary pT1 high-grade bladder cancer. Therefore, older age by itself should not necessarily be a reason to withhold BCG treatment. Treatment decisions should be individualized and take into account the patient's overall health, tumor characteristics, treatment tolerance, and preferences.
This study is retrospective, meaning that researchers analyze information that has already been collected during routine medical care. It does not assign patients to different treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with primary pT1 high-grade urothelial bladder cancer who underwent transurethral resection of the bladder tumor, followed by repeat resection confirming no residual tumor, and subsequently received intravesical BCG therapy according to current EAU guidelines. The retrospective multicenter cohort includes 64 patients. Patients are evaluated according to age, with comparisons using age thresholds of 70 and 75 years. The study population includes both male and female patients and represents patients treated with standard-of-care BCG therapy in routine clinical practice.
Key inclusion criteria (1 listed)
- Treatment: TUR-B + Re-TUR-B + BCG (≥6 instillations)
Key exclusion criteria (3 listed)
- Re-TUR-B > 56 after TUR-B
- Residual tumor on re-TUR-B histology
- non-urothelial histology
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 |
|---|---|---|
| Intravesical BcgThis is a retrospective observational study with no assigned study intervention. Patients received standard-of-care Bacillus Calmette-Guérin (BCG) therapy for primary pT1 high-grade bladder cancer as part of routine clinical care, following transurethral resection and repeat resection confirming no residual tumor. BCG was administered intravesically according to current European Association of Urology (EAU) recommendations. The study does not compare different BCG preparations, doses, or treatment schedules. Instead, it evaluates whether patient age is associated with recurrence-free survival, progression-free survival, and overall survival after standard BCG treatment. No experimental treatment or change in clinical management is performed as part of the study. | Drug | – |
Primary outcome
Recurrence-free survival
Time frame: From date of initial transurethral resection (Day 1) until first documented recurrence or last follow-up, assessed retrospectively up to 69 months.
Time from initial transurethral resection to first documented bladder cancer recurrence or last follow-up.
2 secondary outcomes
Progression-free survival
Time frame: From date of initial transurethral resection (Day 1) until first documented disease progression or last follow-up, assessed retrospectively up to 69 months.
Overall survival
Time frame: From date of initial transurethral resection (Day 1) until death from any cause or last follow-up, assessed retrospectively up to 69 months.
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 1 Sep 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and NMIBC, run by Insel Gruppe AG, University Hospital Bern.
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 1 inclusion and 3 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Recurrence-free survival (time frame: From date of initial transurethral resection (Day 1) until first documented recurrence or last follow-up, assessed retrospectively up to 69 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 1 Sep 2026.