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RecruitingNCT07763197SCORE-NMIBCUpdated Aug 13, 2026

Sample Collection for Ongoing Research and Product Evaluation Study - Non-muscle Invasive Bladder Cancer (SCORE-NMIBC)

An observational study in Non-Muscle Invasive Bladder Cancer, NMIBC and High-risk Non-Muscle Invasive Bladder Cancer, sponsored by Natera, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Natera, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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)").

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.

02

Conditions studied

  • Non-Muscle Invasive Bladder Cancer
  • NMIBC
  • High-risk Non-Muscle Invasive Bladder Cancer

Keywords

  • Non-Muscle Invasive Bladder Cancer
  • NMIBC
  • Cystectomy
  • High-grade T1 Bladder Cancer
  • High-grade Ta Bladder Cancer
03

In context

Non-Muscle Invasive Bladder Neoplasms

294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.

This study's planned enrollment of 400 is above the median of 300 across 49 observational studies indexed under Non-Muscle Invasive Bladder Neoplasms.

Browse Non-Muscle Invasive Bladder Neoplasms studies →

Lead sponsor

Natera, Inc. is the lead sponsor of 36 studies on the registry; 11 are open to participants now.

Browse Natera, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants 18 years of age or older diagnosed with Non-muscle Invasive Bladder Cancer (NMIBC) prior to receiving treatment.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient is at least 18 years of age or older.
  2. performance status ≤ 2.

  3. 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):

    1. High grade T1.
    2. Any recurrent, High-grade TA.
    3. High grade TA, >3 cm (or multifocal).
    4. BCG failure in high grade patient.

    5. Any variant histology.*

      *e.g. Micropapillary, plasmacytoid, small cell/neuroendocrine, and sarcomatoid histologies (in pure or mixed form with associated urothelial carcinoma)

    6. Any lymphovascular invasion.
    7. Any high grade prostatic urethral invasion.

  4. Meet the following criteria:

    a. 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.

  5. Willing and able to tolerate blood draws according to Natera standard process.
  6. Willing to provide urine collection samples.
  7. Able to consent to and provide residual tumor tissue for research.
  8. Willing and able to comply with the study requirements.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or breastfeeding.
  2. 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.
  3. Diagnosis of >T1 bladder cancer at time of enrollment.
  4. Tumor tissue unavailable and/or consists only of carcinoma in situ (CIS) disease.
  5. 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.
  6. History of bone marrow or organ transplant.
  7. Serious medical conditions that may adversely affect ability to participate in the study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 3 Years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Jul 2032, 72 months later.

Of 29 observational studies under Non-Muscle Invasive Bladder Neoplasms, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 30. This study's planned 72 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2026
First posted
Aug 13, 2026
StartEst.
Jul 27, 2026
Primary completionEst.
Jul 2032
CompletionEst.
Jul 2032
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07763197
Lead sponsor
Natera, Inc.
Responsible party
Sponsor
First posted
Aug 13, 2026
Start date
Jul 27, 2026 (estimated)
Primary completion
Jul 2032 (estimated)
Completion
Jul 2032 (estimated)
Last update
Aug 13, 2026

Study contacts

SCORE-NMIBC Study team
Contact
contactscorenmibc@natera.com
650-489-9050

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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