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

NCT07793240 | Not Yet Recruiting

• 1 other identifier: IRB00569996
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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 prostpective trials for perioperative therapy in UTUC.

Conditions

Upper Tract Urothelial Carcinoma

Keywords

ctDNA

Outcome Measures

Primary Outcomes (3)

• Percent of of tumor informed ctDNA test results on Signatera platform available

  Percent of ctDNA results available at the protocol specified timepoints.

  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

  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.

  until end of surveillance or adjuvant therapy, approximately 5 years

Study Arms (1)

High Grade (HG) Upper Tract Urothelial Cancer (UTUC)

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

Interventions

Signatera testing DIAGNOSTIC_TEST

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.

High Grade (HG) Upper Tract Urothelial Cancer (UTUC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

Study Officials

• Jeannie Hoffman-Censits, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sin Chan, MS

CONTACT

410-614-3630; schan44@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

US (1)