Collects samples and data from people with non-muscle invasive bladder cancer
Collects blood, urine and tumor samples to study tests for monitoring bladder cancer.
Plain-language title generated from the registry record
Registry title: Sample Collection for Ongoing Research and Product Evaluation Study - Non-muscle Invasive Bladder Cancer (SCORE-NMIBC)
Key facts
- Where
- Austin, United StatesSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with suspected high-risk non-muscle invasive bladder cancer. They give blood, urine and leftover tumor tissue for research.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- High-risk non-muscle invasive bladder cancer, up to stage T1. Cohort A: can have bladder treatment or surgery, or has finished treatment and is under follow-up. Cohort B: having the bladder removed (cystectomy).
- Earlier treatment
- People in Cohort A may have had treatment in the bladder or by drug into the body, and now be in follow-up. Cancer treatment within the past year is an exclusion, except treatment for non-muscle invasive bladder cancer.
- Biomarker or test result
- No specific gene change is asked for. Tumor tissue must be available and cannot be carcinoma in situ (CIS) only.
Main reasons for not taking part
- Pregnant or breastfeeding.
- Bladder cancer beyond stage T1 at enrollment.
- Other active cancer, or other cancer treated within the past year (some exceptions).
- Had or plans ctDNA or utDNA testing for residual disease (MRD), except one-time gene profiling for drug choice.
- Past bone marrow or organ transplant.
Read by machine on 9 November 2026.
Where in United States
- Natera, Inc.Austin, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Natera, Inc.
- Trial code
- NCT07763197
- Record updated
- 13 August 2026
- Original description
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)").Read full original descriptionShow less
Sample Collection for Ongoing Research and Product Evaluation Study - Non-muscle Invasive Bladder Cancer (SCORE-NMIBC)
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)").
Inclusion: 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; Note: The AUA/SUO risk stratification for primary non-muscle invasive bladder cancer will be used to determine high risk of tumor progression based on clinic and pathologic prognostic factors (Holzbeierlein et al., 2024):; High grade T1; Any recurrent, High-grade TA; High grade TA, >3 cm (or multifocal); BCG failure in high grade patient; Any variant histology.*; *e.g. Micropapillary, plasmacytoid, small cell/neuroendocrine, and sarcomatoid histologies (in pure or mixed form with associated urothelial carcinoma); Any lymphovascular invasion; Any high grade prostatic urethral invasion; Meet the following criteria:; Cohort A: i. Participant has high risk ≤ T1 bladder cancer and is eligible for intravesical therapy or cystectomy. ii. Participant has been treated with intravesical and/or systemic therapy for high risk ≤ T1 bladder cancer and is entering surveillance. b. Cohort B i. Participant has high risk ≤ T1 bladder cancer and undergoing primary treatment with cystectomy. ii. Patients undergoing cystectomy following recurrence or progression of high risk ≤ T1 bladder cancer and where ≤ T1 bladder cancer is confirmed on cystectomy surgical pathology; Willing and able to tolerate blood draws according to Natera standard process; Willing to provide urine collection samples; Able to consent to and provide residual tumor tissue for research; Willing and able to comply with the study requirements.
Exclusion: 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; 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; Diagnosis of >T1 bladder cancer at time of enrollment; Tumor tissue unavailable and/or consists only of carcinoma in situ (CIS) disease; History of bone marrow or organ transplant; Serious medical conditions that may adversely affect ability to participate in the study; Pregnant or breastfeeding.