Recruiting

Observational Study

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT07726602

Conditions

Muscle Invasive Bladder Urothelial Carcinoma

Stage II Bladder Cancer AJCC v8

Stage IIIA Bladder Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

This study investigates the feasibility of the Labcorp Plasma Detect, which is an assay (test) that looks for circulating tumor DNA (ctDNA) in patients who have muscle-invasive (MI) urothelial carcinoma (also known as MI bladder cancer, MIBC). During this study, tissue, blood and urine samples will also be analyzed to help the study team better understand this type of cancer and a patient's response to treatment.

Conditions

Muscle Invasive Bladder Urothelial Carcinoma

Stage II Bladder Cancer AJCC v8

Stage IIIA Bladder Cancer AJCC v8

Study ID

NCT07726602

Start date

Jun 29, 2026

Status verified date

Aug, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ability to understand and willingness to provide written informed consent
  • Age ≥ 18 yr at the time of consent. Eligibility is limited to adults since MIBC is not prevalent in persons under the age of 18 yr. Persons of all genders, gender identities, races, and ethnicity will be included
  • New diagnosis of histologically confirmed muscle-invasive UC (TNM classification (UICC/AJCC 8th edition) of cT2-4aN0-2M0 at pathological examination and approved for either (1) systemic NAT followed by RC or (2) CRT

  • Plan for treatment of MIBC with curative intent with one of the three SOC treatments as listed above

  • Surgical resection, if planned, must include removal of the bladder and bilateral pelvic lymph node dissection if not already included
  • Radiation therapy, if planned, must include transurethral resection of bladder tumor, followed by image guided radiotherapy plus sensitizing chemotherapy
  • Representative FFPE tumor specimens from biopsy at diagnosis (including TURBT) in paraffin blocks (blocks preferred) or at least 10 unstained and 1 H\&E slides. Biopsied tumor specimen quality must have been verified by local pathology review. Fine-needle aspiration, brushing, cell pellet from pleural effusion, and lavage samples are not acceptable. For core-needle biopsy specimens, at least three cores should be submitted for evaluation
  • For participants who have partners of childbearing potential: Partner and/or participant must not be planning to conceive and must follow guidelines and recommendations per the SOC for their various therapeutic interventions

Exclusion Criteria:

  • Ongoing treatment with an approved or investigational anti-cancer therapy for a cancer that is distinct from UC. Hormone-replacement therapy or oral contraceptives are allowed. Ongoing systemic therapy for bladder cancer will not be exclusionary, but enrollment of this population will be limited
  • Previous or concurrent cancer that is distinct from the cancer under investigation in primary site or histology, except treated cutaneous basal cell carcinoma or squamous cell carcinoma, low or intermediate risk prostate cancer under active surveillance, myeloproliferative disorders or indolent hematologic malignancies that do not require active systemic therapy, and small renal masses under active surveillance. Any cancer curatively treated >two years prior to the first treatment for bladder cancer is permitted

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients undergo blood, tissue, and urine sample collection and have their medical records reviewed on study.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Concordance between a recurrence and ctDNA status [ Time Frame: Up to study completion. Up to 5 years with the continuation of Years 4-5 study activities based on the results of the Year 3 interim review ]

Central Contacts and Locations

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

OHSU Knight Cancer Institue Clinical Trials Information

503-494-1080trials@ohsu.edu

Principal Investigator:

Jen-Jane Liu

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2026-08-14.