Circulating Tumor DNA (ctDNA) in High Grade Upper Tract Urothelial Cancer (UTUC)

Exploring the Use of Tumor Informed Circulating Tumor DNA (ctDNA) in High Grade Upper Tract Urothelial Cancer (UTUC)

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07793240

Enrollment

Registered

2026-08-28

Start date

2026-10-01

Completion date

2029-10-01

Last updated

2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Tract Urothelial Carcinoma

Keywords

ctDNA

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTSignatera 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* HG UTUC patients planned for systemic therapy and or surgical intervention that will have ctDNA Signatera testing.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Percent of of tumor informed ctDNA test results on Signatera platform available	until end of surveillance or adjuvant therapy, approximately 5 years	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	Up to approximately 5 years	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	until end of surveillance or adjuvant therapy, approximately 5 years	Number of patients with ctDNA decline to zero post-treatment with complete response per RECIST 1.1.

Countries

United States

Contacts

CONTACTSin Chan, MS

schan44@jhmi.edu410-614-3630

PRINCIPAL_INVESTIGATORJeannie Hoffman-Censits, MD

Johns Hopkins University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026