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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05630131
• Other study ID #: LCCC2208
• Status: Active, not recruiting
• Start date: January 10, 2023
• Est. completion date: April 19, 2025

Study information

• Verified date: March 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: April 19, 2025
• Est. primary completion date: April 19, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Muscle-Invasive Bladder Carcinoma
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
United States	North Carolina Cancer Hospital (UNC)	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of cell-free plasma ctDNA collection	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	Feasibility of urine ctDNA collection	The feasibility of urine ctDNA collection will be estimated by the percentage of specimens that hat yield a ctDNA result.	Up to 2 years

External Links

•   University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials