Blood test for tumor DNA in muscle-invasive bladder cancer
Studies a blood test that looks for tumor DNA in adults with bladder cancer.
Plain-language title generated from the registry record
Registry title: Tumor-informed ctDNA in Muscle-invasive Bladder Cancer for Evaluation of Residual/Recurrent Disease - the TiMBER Trial
Key facts
- Where
- Portland, United StatesSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed muscle-invasive bladder cancer who plan to have standard treatment meant to remove all of the disease. It studies a blood test that looks for tumor DNA.
- Age
- 18 years or older
- Sex
- All genders can join.
- Disease stage
- Newly diagnosed, biopsy-confirmed muscle-invasive urothelial cancer of the bladder, stage cT2-4aN0-2M0 (TNM, AJCC 8th edition).
- Earlier treatment
- Plan to have one of three standard treatments: chemotherapy or similar drug treatment before surgery then removal of the bladder, or chemoradiotherapy. Ongoing systemic therapy for bladder cancer is allowed, but enrollment of such people is limited.
- Biomarker or test result
- A tumor tissue sample from the diagnostic biopsy (including TURBT) must be available, in a paraffin block or at least 10 unstained slides and 1 H&E slide.
Main reasons for not taking part
- Ongoing anti-cancer treatment for a cancer other than bladder cancer
- Another past or current cancer of a different site or type, with a few exceptions
- Partner or participant planning to conceive
Read by machine on 9 November 2026.
Where in United States
- OHSU Knight Cancer InstitutePortland, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- OHSU Knight Cancer Institute
- Trial code
- NCT07726602
- Record updated
- 14 August 2026
- Original 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.Read full original descriptionShow less
Tumor-informed ctDNA in Muscle-invasive Bladder Cancer for Evaluation of Residual/Recurrent Disease - the TiMBER Trial
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.
Inclusion: 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: 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.