NMIBCBLASTNCT07893509
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
An observational study of NMIBC and MIBC, run by Bladder Cancer Advocacy Network at 1 site in United States.
Trial summary
This study aims to better understand how treatment choices impact outcomes for patients with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC), as well as the factors that influence treatment decisions made by patients and their healthcare providers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NMIBC, MIBC, Muscle Invasive Bladder Cancer (MIBC)
- What is being tested?
- This is a non-interventional, observational, prospective study.
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2027to May 2032
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients 18 and over with NMIBC or MISC in the United States who are being treated at one of the participating sites, and meet the eligibility criteria.
Who may be able to join
- Arms I-IV
- Meet criteria for intermediate risk or high risk (BCG naïve, BCG exposed or BCG unresponsive disease)
- English speakers
- 18 years of age or older
- Ability to understand and the willingness to provide an informed consent
- Pathology documentation from any hospital/clinic/medical center, and
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- Predominant urothelial carcinoma histology in the specimen
- Patients undergoing any treatment including observation are eligible for inclusion
- Patients enrolling on clinical trial are eligible for participation
- Any patient previously meeting criteria for BCG unresponsiveness who has a recurrence will be eligible for trial in category of BCG unresponsiveness even if last BCG was more than 1 year ago
- Arm V:
- Diagnosed with stage II-IIIB muscle-invasive bladder cancer without evidence of distant metastases
- 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Ability to understand and the willingness to provide an informed consent
- Histologically confirmed urothelial carcinoma of the bladder
- The patient is deemed a candidate for and plans to undergo radical cystectomy
Who cannot join
- Arms I-IV
- Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation)
- Previous history of cystectomy or radiation therapy for bladder cancer
- Previous history of muscle-invasive bladder cancer or metastatic bladder cancer
- Untreated upper tract urothelial carcinoma
- Incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening
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- Unable to provide written informed consent
- Unable to be contacted for research surveys
- Unable to provide Pathology documentation from any hospital/clinic/medical center
- Unable to answer patient questionnaires
- Arm V:
- Evidence of metastatic disease at enrollment
- Any small cell (neuroendocrine) component in the pathology (past or current presentation)
- Prior history of radiation therapy for bladder cancer
- Inability or unwillingness to undergo radical cystectomy (e.g., patient opts for primary trimodality therapy).
- Prior systemic therapy for urothelial carcinoma, unless it is the NAT for the current MIBC diagnosis.
- Untreated upper tract urothelial carcinoma.
- Unable to provide written informed consent.
- Not willing or able to adhere with the study procedures
- Active secondary malignancy
- Diagnosis of a malignancy within 3 years of bladder cancer diagnosis, with the exception of low-risk prostate cancer managed with active surveillance, small renal cell carcinoma managed with active surveillance, and skin cancer managed with active surveillance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vice President, Research contact
United States1 site
UT Southwestern Medical Center
Dallas, Texas, 75390
Sonobia Garrett, (214) 645-8787, Sonobia.Garrett@UTSouthwestern.edu
About this study
Official title: Understanding the Outcomes and Rationale for Treatment Decisions in Patients With Intermediate and High-risk Nonmuscle Invasive Bladder Cancer and Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer: A Multi-center Prospective Observational Trial.
This study aims to better understand how treatment choices impact outcomes for patients with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC), as well as the factors that influence treatment decisions made by patients and their healthcare providers. The study will also include patients with muscle-invasive bladder cancer (MIBC). In addition to receiving standard care and routine follow up, these patients will provide blood samples over time. Researchers will analyze these samples for circulating tumor DNA (ctDNA), small fragments of DNA released into the bloodstream by cancer cells, to monitor how the cancer responds to treatment.
The information gained from this study may help improve treatment planning, disease monitoring, and overall outcomes for patients with bladder cancer.
Read the detailed description
This is a multi-center study whose aim is to understand outcomes based on treatment decisions for patients with intermediate and high risk NMIBC and to understand rationale for treatment decisions for patients and providers. The study will also enroll participants with MIBC who will receive longitudinal plasma ctDNA biomarker profiling in addition to their standard-of-care therapy and disease surveillance. The study will explore the use of non-invasive plasma ctDNA biomarkers to capture disease evolution and response to therapy for the potential development of an assay for early detection of recurrence and/or metastatic relapse in patients with MIBC.
- Being tested
- This is a non-interventional, observational, prospective study.
- Keywords
- NMIBC, non-muscle invasive bladder cancer, muscle invasive bladder cancer, MIBC, bladder cancer, Bladder Neoplasms, Bladder Tumors, Cancer of Bladder, Malignant Tumor of Urinary Bladder, Neoplasms, Bladder, Urinary Bladder Cancer, Blue Light Cystoscopy
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a non-interventional, observational, prospective study.Other
This is a non-interventional, observational prospective study: Arms I-V reflect patient/provider choices, and patients may receive multiple interventions. This is a non-interventional observational study, exposures are not study-assigned interventions.
| Study group | Role | What they receive |
|---|---|---|
| Arm I: IR NMIBC | Patients with Intermediate Risk non-muscle invasive bladder cancer Receives: Other: This is a non-interventional, observational, prospective study. | |
| Arm II: HR BCG naïve NMIBC | Non-Muscle I invasive Bladder Cancer who have never received BCG, or patients who had a complete response to BCG and relapsed more than 24 months after their last BCG dose. Receives: Other: This is a non-interventional, observational, prospective study. | |
| Arm Ill: HR BCG exposed NMIBC | Includes:
* BCG-resistant NMIBC: Persistent or recurrent high-grade Ta or CIS disease at 3mo evaluation after at least 5/6 doses induction BCG.
* Delayed relapse after inadequate BCG: Although maintenance BCG should always follow successful induction BCG according to the guidelines, many patients only receive induction without maintenance. Disease-free at the 3mo evaluation, so the earliest relapse would be 6mo after initial diagnosis. Latest relapse that would be considered would be a high-grade recurrence 24mo after initial diagnosis.
* Delayed relapse after adequate BCG: Disease-free after induction and at least one course of maintenance BCG (or second round of induction BCG), but subsequently experience a high-grade recurrence outside of the BCG-unresponsive window (>6mo for Ta/T1 and >12mo for CIS). Since a high-grade relapse beyond 24mo after the last dose of BCG would probably respond well to BCG again, this disease state would include only patients with relapse up to 24mo. Receives: Other: This is a non-interventional, observational, prospective study. | |
| Arm IV: HR BCG unresponsive NMIBC | Patients meeting the definition of BCG-unresponsive disease. Patients with HR NMIBC, "Adequate" induction + maintenance BCG (mBCG): at least 5/6 doses induction, plus at least 2/3 doses maintenance or at least 5/6 doses reinduction
Categories of patients to include in BCG unresponsive arm:
1. - patients with ≥ T1 HG disease on the first assessment following adequate induction BCG
2. - patients with ≥ Ta HG disease within 6 months of adequate induction + maintenance BCG
3. - patients with any component of CIS within 12 months of adequate induction + maintenance BCG
4. - Any patient previously meeting criteria for BCG unresponsiveness who has a recurrence will be eligible for trial in category of BCG unresponsiveness even if last BCG was more than 1 year ago. Receives: Other: This is a non-interventional, observational, prospective study. | |
| Arm V: Muscle Invasive Bladder Cancer | Muscle Invasive Cancer who receive ctDNA profiling over time in addition to receiving standard of care, which includes a radical cystectomy. This group includes those who choose adjuvant therapy and those who do not. Receives: Other: This is a non-interventional, observational, prospective study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arms I-IV: Overall Mortality at 2 years.
Kaplan-Meier analysis for recurrence-free and progression free survival at 3, 6, 12, 18, 24, and 36 months.
Measured: 36 months
Arm V: MIBC patients (Va adjuvant observation and Vb adjuvant therapy)
The primary outcome is to demonstrate the association of ctDNA and disease free state (DFS longitudinally )
Measured: 36 months
Secondary outcomes (4)
Arms I-IV Secondary Outcomes
For patients with NMIBC, secondary outcomes include patient-reported health-related quality of life, decision-making for patients and providers, cancer outcomes and treatment choices for difference disease stages.
Measured: 36 months
Arm V Secondary Outcomes
For MIBC, to demonstrate the association of NAT-driven ctDNA clearance with pathologic response.
Measured: 3 years
Arm V: MIBC Cohort Va Secondary Measures
For MIBC patients in Cohort Va, to demonstrate the association of post-RC ctDNA status (positive vs. negative at 3 months post-CX point) with disease-free survival
Measured: 3 months
Arm V: MIBC Cohort Vb Secondary Outcomes
For MIBC patients in Cohort Vb, to demonstrate the association of baseline ctDNA status (positive vs negative) with disease-free survival (DFS). For Cohort Vb, association of longitudinal ctDNA dynamics post-definitive therapy with DFS.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startMar 2027 (estimated)
- Primary completionMay 2032 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMIBCStudies 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
- Prospective
- Enrolment
- 1,400 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Bladder Cancer Advocacy Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yair Lotan, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893509
- Sponsor's protocol ID
- BCAN-BLAST-001
- Acronym
- BLAST
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share summary data (ie publish) but not raw data
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Outcomes and Rationale for Treatment Decisions in Patients With Intermediate and High-risk Nonmuscle Invasive Bladder Cancer and Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer: A Multi-center Prospective Observational Trial.
- ClinicalTrials.gov ID
- NCT07893509
- Acronym / sponsor ID
- BLAST / BCAN-BLAST-001
- Keywords
- NMIBC, non-muscle invasive bladder cancer, muscle invasive bladder cancer, MIBC, bladder cancer, Bladder Neoplasms, Bladder Tumors, Cancer of Bladder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Bladder Cancer Advocacy NetworkUniversity, hospital or other
- Study start
- Mar 2027 (estimated)
- Primary completion
- May 2032 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 26 Oct 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 aims to better understand how treatment choices impact outcomes for patients with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC), as well as the factors that influence treatment decisions made by patients and their healthcare providers. The study will also include patients with muscle-invasive bladder cancer (MIBC). In addition to receiving standard care and routine follow up, these patients will provide blood samples over time. Researchers will analyze these samples for circulating tumor DNA (ctDNA), small fragments of DNA released into the bloodstream by cancer cells, to monitor how the cancer responds to treatment.
The information gained from this study may help improve treatment planning, disease monitoring, and overall outcomes for patients with bladder cancer.
Detailed description
This is a multi-center study whose aim is to understand outcomes based on treatment decisions for patients with intermediate and high risk NMIBC and to understand rationale for treatment decisions for patients and providers. The study will also enroll participants with MIBC who will receive longitudinal plasma ctDNA biomarker profiling in addition to their standard-of-care therapy and disease surveillance. The study will explore the use of non-invasive plasma ctDNA biomarkers to capture disease evolution and response to therapy for the potential development of an assay for early detection of recurrence and/or metastatic relapse in patients with MIBC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm I: IR NMIBC | – | Other: This is a non-interventional, observational, prospective study.Patients with Intermediate Risk non-muscle invasive bladder cancer |
| Arm II: HR BCG naïve NMIBC | – | Other: This is a non-interventional, observational, prospective study.Non-Muscle I invasive Bladder Cancer who have never received BCG, or patients who had a complete response to BCG and relapsed more than 24 months after their last BCG dose. |
| Arm Ill: HR BCG exposed NMIBC | – | Other: This is a non-interventional, observational, prospective study.Includes: * BCG-resistant NMIBC: Persistent or recurrent high-grade Ta or CIS disease at 3mo evaluation after at least 5/6 doses induction BCG. * Delayed relapse after inadequate BCG: Although maintenance BCG should always follow successful induction BCG according to the guidelines, many patients only receive induction without maintenance. Disease-free at the 3mo evaluation, so the earliest relapse would be 6mo after initial diagnosis. Latest relapse that would be considered would be a high-grade recurrence 24mo after initial diagnosis. * Delayed relapse after adequate BCG: Disease-free after induction and at least one course of maintenance BCG (or second round of induction BCG), but subsequently experience a high-grade recurrence outside of the BCG-unresponsive window (>6mo for Ta/T1 and >12mo for CIS). Since a high-grade relapse beyond 24mo after the last dose of BCG would probably respond well to BCG again, this disease state would include only patients with relapse up to 24mo. |
| Arm IV: HR BCG unresponsive NMIBC | – | Other: This is a non-interventional, observational, prospective study.Patients meeting the definition of BCG-unresponsive disease. Patients with HR NMIBC, "Adequate" induction + maintenance BCG (mBCG): at least 5/6 doses induction, plus at least 2/3 doses maintenance or at least 5/6 doses reinduction Categories of patients to include in BCG unresponsive arm: 1. - patients with ≥ T1 HG disease on the first assessment following adequate induction BCG 2. - patients with ≥ Ta HG disease within 6 months of adequate induction + maintenance BCG 3. - patients with any component of CIS within 12 months of adequate induction + maintenance BCG 4. - Any patient previously meeting criteria for BCG unresponsiveness who has a recurrence will be eligible for trial in category of BCG unresponsiveness even if last BCG was more than 1 year ago. |
| Arm V: Muscle Invasive Bladder Cancer | – | Other: This is a non-interventional, observational, prospective study.Muscle Invasive Cancer who receive ctDNA profiling over time in addition to receiving standard of care, which includes a radical cystectomy. This group includes those who choose adjuvant therapy and those who do not. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 and over with NMIBC or MISC in the United States who are being treated at one of the participating sites, and meet the eligibility criteria.
Key inclusion criteria (17 listed)
- Arms I-IV
- Meet criteria for intermediate risk or high risk (BCG naïve, BCG exposed or BCG unresponsive disease)
- English speakers
- 18 years of age or older
- Ability to understand and the willingness to provide an informed consent
Key exclusion criteria (21 listed)
- Arms I-IV
- Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation)
- Previous history of cystectomy or radiation therapy for bladder cancer
- Previous history of muscle-invasive bladder cancer or metastatic bladder cancer
- Untreated upper tract urothelial carcinoma
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 |
|---|---|---|
| This is a non-interventional, observational, prospective study.This is a non-interventional, observational prospective study: Arms I-V reflect patient/provider choices, and patients may receive multiple interventions. This is a non-interventional observational study, exposures are not study-assigned interventions. | Other | Arm I: IR NMIBC, Arm II: HR BCG naïve NMIBC, Arm IV: HR BCG unresponsive NMIBC, Arm Ill: HR BCG exposed NMIBC, Arm V: Muscle Invasive Bladder Cancer |
Primary outcome
Arms I-IV: Overall Mortality at 2 years.
Time frame: 36 months
Kaplan-Meier analysis for recurrence-free and progression free survival at 3, 6, 12, 18, 24, and 36 months.
Arm V: MIBC patients (Va adjuvant observation and Vb adjuvant therapy)
Time frame: 36 months
The primary outcome is to demonstrate the association of ctDNA and disease free state (DFS longitudinally )
4 secondary outcomes
Arms I-IV Secondary Outcomes
Time frame: 36 months
Arm V Secondary Outcomes
Time frame: 3 years
Arm V: MIBC Cohort Va Secondary Measures
Time frame: 3 months
Arm V: MIBC Cohort Vb Secondary Outcomes
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. We will share summary data (ie publish) but not raw data
Related trials for NMIBC
RecruitingPhase 1
A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
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Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer
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Active, not recruitingPhase 3
A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)
Non-Muscle Invasive Bladder Neoplasms
RecruitingPhase 2
Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer
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RecruitingPhase 3
A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
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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.
Vice President, Research contact
Yair Lotan, MD principal investigator
University of Texas Southwestern Medical Center
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 NMIBC and MIBC, run by Bladder Cancer Advocacy Network at 1 site in United States.
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 17 inclusion and 21 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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Program Officer ((240) 743-3172, BLAST@bcan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arms I-IV: Overall Mortality at 2 years. (time frame: 36 months). The study lists 2 primary outcomes in all. 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 26 Oct 2026.