Tumor-informed ctDNA in Muscle-invasive Bladder Cancer for Evaluation of Residual/Recurrent Disease - the TiMBER Trial
OHSU Knight Cancer Institute
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 t…
Interventions
- OtherNon-Interventional Study
Non-interventional study
Location
- OHSU Knight Cancer InstitutePortland, Oregon