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

Sponsor

UNC Lineberger Comprehensive Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05630131

Collaborator

(none)

Enrollment

Location

39.6

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Muscle-Invasive Bladder Carcinoma

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jan 10, 2023

Anticipated Primary Completion Date :

Apr 30, 2026

Anticipated Study Completion Date :

Apr 30, 2026

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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.