BLAST
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.
Sponsor study identifier
observational
1,400
1 country
1
Study Start
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
May 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 19, 2026
Actual (reported)October 26, 2026
Actual (reported)March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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 )
36 months
Arms I-IV Secondary Outcomes
36 months
Patients with Intermediate Risk non-muscle invasive bladder cancer
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.
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.
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.
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.
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
The biospecimens collected from participants in this study will not be used as part of a biorepository. Deidentified Tumor, Blood, and Urine samples will be collected for ctDNA isolation and analysis. Extracted ctDNA will be evaluated via tumor informed assay to detect molecular residual disease (MRD), monitor treatment response, and track circulating tumor burden. Residual samples may be retained while the research study continues and may be used as permitted by law.
Yair Lotan, MD
University of Texas Southwestern Medical Center
Vice President, Research
CONTACT
First Submitted
October 19, 2026
First Posted
October 26, 2026
Study Start
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
May 2032
EstimatedArm V Secondary Outcomes
3 years
Arm V: MIBC Cohort Va Secondary Measures
3 months
Arm V: MIBC Cohort Vb Secondary Outcomes
3 years
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.
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.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 26, 2026
Record last verified: 2026-10
We will share summary data (ie publish) but not raw data
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Source: ClinicalTrials.gov.
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