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Observational Study for Muscle-Invasive Bladder Cancer

This study, called the TiMBER Trial, is looking at a new test called Labcorp Plasma Detect. This test checks for circulating tumor DNA (ctDNA) in your blood, which are tiny pieces of cancer DNA. The study is for people with muscle-invasive bladder cancer (MIBC), which is bladder cancer that has grown into the muscle layer of the bladder. Researchers want to see if the results from this test match up with whether your cancer comes back or responds to treatment. They will also collect blood, tissue, and urine samples to learn more about this type of cancer and how people respond to treatment. You can join if you are 18 or older and have a new diagnosis of this cancer.

Study design
This is an observational study involving 100 participants. It will collect samples and review medical records to see how ctDNA levels relate to cancer recurrence.
What's involved
You would provide blood, tissue, and urine samples. Your medical records will also be reviewed by the study team.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to 5 years, with continued study activities based on interim reviews.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07726602

Tumor-informed ctDNA in Muscle-invasive Bladder Cancer for Evaluation of Residual/Recurrent Disease - the TiMBER Trial

Recruiting
Not specifiedAges 18+Observational
OHSU Knight Cancer Institute
~100 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Concordance between a recurrence and ctDNA status
Measured over 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

Conditions

Muscle Invasive Bladder Urothelial Carcinoma
Stage II Bladder Cancer AJCC v8
Stage IIIA Bladder Cancer AJCC v8

Explore related trials

Bladder Urothelial CarcinomaCirculating Tumor-Derived DNA Negative

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • Jen-Jane Liu · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute

Who to contact

Jen-Jane Liu
[email protected]
503-346-1500
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

What this trial measures

  • Concordance between a recurrence and ctDNA statusUp 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.