Could a simple blood or urine test spot bladder cancer earlier?
NCT ID NCT07763197
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This study is collecting blood, urine, and tumor tissue samples from about 400 adults with suspected high-risk non-muscle invasive bladder cancer. The goal is to find biological markers that could lead to new tests for detecting and monitoring this type of cancer. Participants will provide samples during standard care procedures, and researchers will analyze them to see if they can identify signs of cancer. This is a research study, not a treatment trial, so participants will not receive any experimental therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- No drug or treatment is being tested. This study collects blood, urine, and tumor tissue samples for research.
- What this could lead to
- If successful, this could help develop better blood or urine tests to detect and monitor bladder cancer, potentially improving early detection and follow-up care.
- What could go wrong
- This is an early research study focused on sample collection, not a treatment trial. It may not lead to a usable test, and any future test would need much more validation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants 18 years of age or older diagnosed with Non-muscle Invasive Bladder Cancer (NMIBC) prior to receiving treatment.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient is at least 18 years of age or older. 2. Eastern Cooperative Oncology Group 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: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Natera, Inc.
RECRUITINGAustin, Texas, 78753, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can heated saline during bladder surgery stop tumors from coming back?
- Radiation instead of bladder removal: a new option for Hard-to-Treat bladder cancer?
- Can an immunotherapy plus chemotherapy keep High-Risk bladder cancer at bay?
- Can a bladder rinse before surgery keep bladder cancer at bay?
- Timing chemotherapy around bladder surgery may cut recurrence