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

Part of paid clinical trials in Austin, Texas.

Sponsor: Natera, Inc.
Study ID: NCT07763197
Status: Recruiting

Conditions

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

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Study Details

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)").

Key Dates

First listed: Aug 13, 2026
Start date: Jul 27, 2026
Status verified: Jul 2026
Primary completion: Jul 31, 2032
Completion: Jul 31, 2032

Study Design

Enrollment: 400 participants (estimated)

Arms

Arm: 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.
Arm: 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.
Arm: 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.