Sample Collection for Ongoing Research and Product Evaluation Study - Non-muscle Invasive Bladder… (NCT07763197) | Clinical Trial Compass
RecruitingNot Applicable
Sample Collection for Ongoing Research and Product Evaluation Study - Non-muscle Invasive Bladder Cancer (SCORE-NMIBC)
United States400 participantsStarted 2026-07-27
Plain-language summary
The SCORE-NMIBC study is a prospective, multi-center, study designed to collect data and biological samples from participants diagnosed with non-muscle Invasive Bladder Cancer (NMIBC). Study participants will undergo research blood and urine collections, as well as tumor tissue collected as part of a standard-of-care procedure(s), for use in research. Collected samples and data will be analyzed to evaluate biomarkers associated with development and validation of cancer monitoring and detection assays ("Natera cancer monitoring and detection test(s)").
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient is at least 18 years of age or older.
. Eastern Cooperative Oncology Group performance status ≤ 2.
. Patient has a suspected high risk non-muscle invasive bladder cancer.
. High grade T1.
. Any recurrent, High-grade TA.
. High grade TA, \>3 cm (or multifocal).
. BCG failure in high grade patient.
. Any variant histology.\*
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Completed Participants with Blood, Urine and Residual Tissue Specimens Collected
. Prior history and treatment for any cancer (including muscle invasive bladder cancer) within the past year, or if they have any other active cancer, with the exception of participants who have undergone surgical removal of basal or squamous skin cancers, as well as those who have received NMIBC-directed therapy, including those undergoing cystectomy for primary NMIBC or after recurrence/progression of NMIBC.
. Diagnosis of \>T1 bladder cancer at time of enrollment.
. Tumor tissue unavailable and/or consists only of carcinoma in situ (CIS) disease.
. At time of enrollment, has undergone or plans to undergo any ctDNA or utDNA testing to assess MRD, with the exception of one-time comprehensive genomic profiling for therapeutic drug selection.
. History of bone marrow or organ transplant.
. Serious medical conditions that may adversely affect ability to participate in the study.