Non-Muscle Invasive Bladder CancerSCORE-NMIBCNCT07763197
Sample Collection for Ongoing Research and Product Evaluation Study - Non-muscle Invasive Bladder Cancer (SCORE-NMIBC)
An observational study of Non-Muscle Invasive Bladder Cancer and NMIBC, run by Natera, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Muscle Invasive Bladder Cancer, NMIBC, High-risk Non-Muscle Invasive Bladder Cancer
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2026to Jul 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants 18 years of age or older diagnosed with Non-muscle Invasive Bladder Cancer (NMIBC) prior to receiving treatment.
Who may be able to join
- 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.
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- 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.
Who cannot join
- Pregnant or breastfeeding.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Natera, Inc.
Austin, Texas, 78753
Adam ElNaggar, MD, 650-489-9050
About this study
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 the detailed description
The study is designed to evaluate the clinical performance of Natera's molecular residual disease (MRD) assays in detecting ctDNA in patients diagnosed with NMIBC. The goal is to assess the ability of the assay to identify minimal residual disease, monitor disease recurrence, and evaluate treatment response on therapy. No individual test results from the study testing will be provided to participants or their treating clinicians.
Participants who meet the study eligibility criteria will be invited to enroll in the study. Informed consent form (ICF) (paper or electronic) will be signed by the participant prior to study procedures. Participants will provide study-specific blood and urine samples at protocol defined timepoints.
The SCORE-NMIBC study includes two participant cohorts:
Cohort A - Intravesical Therapy and/or Systemic Therapy Cohort B - Cystectomy
Participants may be followed for up to three years, including up to two years of blood and urine collection and up to one year of data-only follow-up.
Tissue Sample Collection:
Residual tissue samples, collected as part of standard-of-care procedures, will also be obtained for study purposes.
- Keywords
- Non-Muscle Invasive Bladder Cancer, NMIBC, Cystectomy, High-grade T1 Bladder Cancer, High-grade Ta Bladder Cancer
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - Intravesical Therapy | Samples collected at enrollment, before repeat TURBT (if done), then every 6 weeks during induction, then every 3 months for 2 years. | |
| Cohort A - Systemic Therapy | Samples collected at enrollment, before repeat TURBT (if done), at treatment start, at first follow-up, then every 3 months for 2 years. | |
| Cohort B - Cystectomy | Samples collected at enrollment, before repeat TURBT (if done), pre- and post-cystectomy (blood only post-op), then every 3 months for 2 years if NMIBC is confirmed on pathology. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Completed Participants with Blood, Urine and Residual Tissue Specimens Collected
The primary outcome will be measured as the number of participants who complete collection of clinically characterized, de-identified whole blood, urine and residual tissue specimens. The planned number of completed participants is 225. The specimens and data will be used in development and validation of cancer monitoring and detection assays.
Measured: 3 Years
Secondary outcomes (1)
Number of Completed Participants with Blood, Urine and Residual Tissue Specimens Evaluated for Biomarkers
The secondary outcome will be measured as the number of completed participants whose clinically characterized, de-identified whole blood, urine and residual tissue specimens are evaluated for biomarkers associated with the development and validation of disease assays. The planned number of completed participants is 225.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start27 Jul 2026 (estimated)
- Primary completionJul 2032 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763197
- Sponsor's protocol ID
- 25-096-NCP
- Acronym
- SCORE-NMIBC
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No