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

August 9, 2026 updated by: Natera, Inc.

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)").

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: SCORE-NMIBC Study team
Phone Number: 650-489-9050
Email: contactscorenmibc@natera.com

Study Locations

United States
- Texas
  - Austin, Texas, United States, 78753
    - Recruiting
    - Natera, Inc.
    - Contact:
      
      Adam ElNaggar, MD
      
      Phone Number: 650-489-9050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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.

Description

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.
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.
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.
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 Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Completed Participants with Blood, Urine and Residual Tissue Specimens Collected Time Frame: 3 Years	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.	3 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Completed Participants with Blood, Urine and Residual Tissue Specimens Evaluated for Biomarkers Time Frame: 3 Years	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.	3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Natera, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 27, 2026

Primary Completion (Estimated)

July 1, 2032

Study Completion (Estimated)

July 1, 2032

Study Registration Dates

First Submitted

July 17, 2026

First Submitted That Met QC Criteria

August 9, 2026

First Posted (Actual)

August 13, 2026

Study Record Updates

Last Update Posted (Actual)