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.
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
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
Patients with muscle invasive bladder urothelial cancer approved for either systemic NAT followed by RC or CRT.
Cohort
Prospective
Non-Interventional Study
Other interventionNon-interventional study
Concordance between a recurrence and ctDNA status
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.
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