The study will evaluate the feasibility of collecting ctDNA data for UTUC patients in perioperative setting and if the data generated can help with design of future prospective trials for perioperative therapy in UTUC.
HG UTUC patients planned for systemic therapy and or surgical intervention that will have ctDNA Signatera testing.
UTUC patients without high grade disease that is not planned for either systemic therapy or surgical intervention and not planned to have ctDNA Signatera testing.
HG UTUC patients planned for systemic therapy and or surgical intervention that will have sequential ctDNA ordered as per standard Signatera testing (approved for patients with high risk urothelial cancer undergoing immunotherapy or in perioperative setting).
Cohort
Prospective
Signatera testing
Diagnostic testStandard Signatera testing for ctDNA at or close to baseline, every 4-6 weeks on treatment, before and after surgical intervention, on surveillance and or adjuvant therapy.
Percent of of tumor informed ctDNA test results on Signatera platform available
Percent of ctDNA results available at the protocol specified timepoints.
Correlation between perioperative ctDNA dynamics in UTUC with pathologic and clinical outcomes in patients with UTUC who proceed to surgery or renal preservation following induction therapy and or surgery
Measured at or close to baseline, q4-6 weeks on treatment, before and after surgical intervention, on surveillance and or adjuvant therapy, approximately 5 years
Number of patients with ctDNA decline to zero and radiographic complete response after treatment
Number of patients with ctDNA decline to zero post-treatment with complete response per RECIST 1.1.
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This trial is not recruiting at the moment. You can still explore other options:
