An observational study in NMIBC, MIBC and Muscle Invasive Bladder Cancer (MIBC), sponsored by Bladder Cancer Advocacy Network. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Bladder Cancer Advocacy Network · Observational
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.
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.
273 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 116 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 210 across 47 observational studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Browse Non-Muscle Invasive Bladder Neoplasms studies →This is the only study on the registry with Bladder Cancer Advocacy Network as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Arms I-IV
Arm V:
Exclusion Criteria:
Arms I-IV
Arm V:
Patients with Intermediate Risk non-muscle invasive bladder cancer
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.
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.
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.
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.
Other: 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.
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.
Time frame: 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 )
Time frame: 36 months
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.
Time frame: 36 months
Arm V Secondary Outcomes
For MIBC, to demonstrate the association of NAT-driven ctDNA clearance with pathologic response.
Time frame: 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
Time frame: 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.
Time frame: 3 years
Plan to share: No — We will share summary data (ie publish) but not raw data
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Non-Muscle Invasive Bladder Neoplasms →