What this study is
Simplified from ClinicalTrials.govStudying how treatment choices affect results, and whether blood tests for tumor DNA can track response, in adults 18 and older with intermediate- or high-risk bladder cancer that has not grown into the muscle wall, or with muscle-invasive bladder cancer. The muscle-invasive group gives blood samples over time during standard care.
Read the original summary from ClinicalTrials.gov
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.
What's being tested
- This is a non-interventional, observational, prospective study.
Intervention · 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 details
- 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.
- Sponsor
- Bladder Cancer Advocacy Network
- Conditions
- NMIBC · MIBC · Muscle Invasive Bladder Cancer (MIBC) · Non Muscle Invasive Bladder Cancer
- Enrolling
- 1,400 people
- Starts
- 2027-03
- Est. completion
- 2032-05
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedAll participants
You may qualify if
- 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
You can't join if
- 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
- 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
You may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUT Southwestern Medical Center
Dallas, Texas, United States
- Sonobia Garrett · Contact(214) 645-8787Sonobia.Garrett@UTSouthwestern.edu
Study team
Sponsor
Bladder Cancer Advocacy Network
Study ID BCAN-BLAST-001
Principal investigator
Yair Lotan, MD
University of Texas Southwestern Medical Center
CONTACT
Vice President, Research
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.