NCT07726602 · OHSU Knight Cancer Institute
Tumor-informed ctDNA in Muscle-invasive Bladder Cancer for Evaluation of Residual/Recurrent Disease - the TiMBER Trial
What this study is about
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).
View original scientific description
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.
Interventions
OTHER
Non-Interventional Study
Non-interventional study
Primary outcome measures
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
Will assess the concordance between a recurrence (assigned using SOC methods) and ctDNA status post definitive treatment among participants who have demonstrated cancer recurrence. Concordance will be evaluated using a time-dependent C index and diagnostic accuracy will be reported with sensitivity, specificity, PPV, and NPV.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Portland, Oregon
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 14, 2026 · Source of record for eligibility and locations