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

Active, not recruiting

• Conditions: Muscle-Invasive Bladder Carcinoma; Bladder Cancer

• Registration Number: NCT05630131
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-29
• Study Start: 2023-01-10
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26
• Primary Completion: 2025-04-19
• Study Completion: 2025-04-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

North Carolina Cancer Hospital (UNC); 🇺🇸 Chapel Hill, North Carolina, United States