Tumor-informed ctDNA in Muscle-invasive Bladder Cancer for Evaluation of Residual/Recurrent Disease - the TiMBER Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry conditions: Muscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
PRIMARY OBJECTIVE:
I. Evaluate the correspondence of cancer recurrence and ctDNA positivity.
OUTLINE: This is an observational study. Patients will undergo prospective sample collection of blood, tissue, and urine to assess levels of tumor DNA based on whole genome sequencing of their cancer. Their medical records will be reviewed on study to see whether levels of ctDNA correlate with disease response to treatment or recurrence.
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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- OHSU Knight Cancer Institute — Portland
Identifiers
NCT: NCT07726602 · STUDY00028122 · NCI-2026-04082 · STUDY00028122