ctDNA in Subjects With Muscle-invasive Bladder Cancer Treated With Trimodality Therapy

November 25, 2025 updated by: UNC Lineberger Comprehensive Cancer Center

Pilot Study to Evaluate the Role for Circulating Tumor DNA (ctDNA) in Monitoring Subjects With Muscle-invasive Bladder Cancer Treated With Trimodality Therapy

The purpose of this prospective biospecimen collection study is to evaluate the feasibility of measuring circulating tumor DNA (ctDNA) in subjects with muscle-invasive bladder cancer (MIBC) treated with trimodality therapy consisting of a maximal transurethral resection of bladder tumor followed by radiation and concomitant chemotherapy.

Cancer cells have unique genes that determine the characteristics of tumors, such as how they will respond to different treatments. The tumor tissue will be used to determine the genes present in cancer cells. Tumor cells sometimes release fragments of DNA into the blood or urine (circulating tumor DNA or ctDNA) and measuring levels of ctDNA may be a way to monitor cancer and predict to determine which treatment works better and what will be the outcome of cancer.

Urine, blood, and tumor tissue are called biospecimens. Biospecimens can help researchers understand how the human body works. Researchers may develop new tests to monitor diseases or new ways to treat diseases. Plasma and urine specimens will be collected before, during, and after the standard-of-care treatment.

This study will estimate the feasibility of collecting plasma ctDNA detection in subjects with MIBC. If this information can be successfully collected and processed, the usefulness of ctDNA to predict tumor response to certain kinds of treatment or disease progression will be evaluated.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • North Carolina Cancer Hospital (UNC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

University of North Carolina Patients

Description

Inclusion Criteria:

  1. Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
  2. A diagnosis of Muscle-invasive Bladder Cancer with a plan to treat it with surgery, radiation, and chemotherapy
  3. Subjects are willing and able to comply with study procedures based on the judgment of the investigator.

Exclusion Criteria:

All subjects must not meet any of the following exclusion criteria prior to enrollment to participate in this study:

  1. Any serious medical or psychiatric disorder that would interfere with the subject's ability to give informed consent.
  2. Incarcerated individuals.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of cell-free plasma ctDNA collection
Time Frame: Up to 2 years
The feasibility of cell-free plasma ctDNA collection will be estimated by the percentage of specimens that yield a ctDNA result.
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of urine ctDNA collection
Time Frame: Up to 2 years
The feasibility of urine ctDNA collection will be estimated by the percentage of specimens that hat yield a ctDNA result.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Investigators

  • Principal Investigator: Matthew I Milowsky, MD, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2023

Primary Completion (Actual)

August 2, 2025

Study Completion (Actual)

August 2, 2025

Study Registration Dates

First Submitted

November 17, 2022

First Submitted That Met QC Criteria

November 17, 2022

First Posted (Actual)

November 29, 2022

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC2208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share IPD with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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