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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05630131

Enrollment

Registered

2022-11-29

Start date

2023-01-10

Completion date

2025-08-02

Last updated

2025-11-28

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

Conditions

Bladder Cancer, Muscle-Invasive Bladder Carcinoma

Keywords

circulating tumor DNA, biospecimen, surgery, radiotherapy, chemotherapy, trimodality

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of cell-free plasma ctDNA collection	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.

Secondary

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

Countries

United States

Outcome results