NCT05630131Completed
ctDNA in Subjects With Muscle-invasive Bladder Cancer Treated With Trimodality Therapy
Pilot Study to Evaluate the Role for Circulating Tumor DNA (ctDNA) in Monitoring Subjects With Muscle-invasive Bladder Cancer Treated With Trimodality Therapy
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1 (actual)
- First submitted
- 17 Nov 2022
- Start date
- 10 Jan 2023
- Primary completion date
- 2 Aug 2025
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Bladder cancer
- NCT number
- NCT05630131
What you commit to
- Study type: Observational
- Participants enrolled: 1
- From 10 Jan 2023 to the primary completion date, 2 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- All subjects must not meet any of the following exclusion criteria prior to enrollment to participate in this study:
Other illness
- Any serious medical or psychiatric disorder that would interfere with the subject's ability to give informed consent.
Other
- Incarcerated individuals.
Who the study is looking for
- Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
- A diagnosis of Muscle-invasive Bladder Cancer with a plan to treat it with surgery, radiation, and chemotherapy
- Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| North Carolina Cancer Hospital (UNC) Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.