NCT07893509Not yet recruiting
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)
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.
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1400 (estimated)
- First submitted
- 19 Oct 2026
- Start date
- 1 Mar 2027
- Primary completion date
- 31 May 2032
- Lead sponsor
- Bladder Cancer Advocacy Network
- Diseases
- Bladder cancer
- NCT number
- NCT07893509
What you commit to
- Study type: Observational
- Planned participants: 1400
- From 1 Mar 2027 to the primary completion date, 31 May 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of cystectomy or radiation therapy for bladder cancer
- Previous history of muscle-invasive bladder cancer or metastatic bladder cancer
- 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.
Other illness
- Evidence of metastatic disease at enrollment
- 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
Other
- Arms I-IV
- Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation)
- 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
- 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:
- Any small cell (neuroendocrine) component in the pathology (past or current presentation)
- Untreated upper tract urothelial carcinoma.
- Unable to provide written informed consent.
- Not willing or able to adhere with the study procedures
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.