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.
This study will provide contemporary data for patients with UTUC in the perioperative setting that is unanticipated to become available through large interventional trials. Preliminary data from this study could inform future prospective trials aimed at intensifying or de-intensifying perioperative therapy in UTUC. The study will assess 1) the feasibility of obtaining tumor informed ctDNA on the Signatera platform in patients with High Grade Upper Tract Urothelial Cancer (HG UTUC) planned for systemic therapy and or surgical intervention, 2) if perioperative ctDNA dynamics in UTUC correlate with pathologic and clinical outcomes in patients with UTUC who proceed to surgery or renal preservation following induction therapy and or surgery, and 3) if perioperative ctDNA dynamics in UTUC are prognostic for survival estimates as they are in muscle invasive bladder cancer (MIBC). Preliminary data from this study may also support clinical decisions of renal retention in patients treated with chemotherapy who chose to defer surgery.
Study Type
OBSERVATIONAL
Enrollment
20
Standard 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.
Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Percent of of tumor informed ctDNA test results on Signatera platform available
Percent of ctDNA results available at the protocol specified timepoints.
Time frame: until end of surveillance or adjuvant therapy, approximately 5 years
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
Time frame: Up to 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.
Time frame: until end of surveillance or adjuvant therapy, approximately 5 years
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