An observational study in Upper Tract Urothelial Carcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Observational
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.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 582 studies on the registry; 71 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 68 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
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Exclusion Criteria:
Patients HG UTUC planned for systemic therapy and or surgical intervention will be recruited and have sequential ctDNA ordered as per standard Signatera testing (approved for patients with high risk urothelial cancer undergoing immunotherapy or in perioperative setting) at or close to baseline, every 4-6 weeks on treatment, before and after surgical intervention, on surveillance and or adjuvant therapy.
Diagnostic Test: Signatera testing
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.
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
Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 29, 2026: start Oct 2026 → Dec 2026, primary completion Oct 2028 → Dec 2028 and completion Oct 2029 → Dec 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins →