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

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

NCT ID: NCT05630131

Condition: Bladder Cancer
Muscle-Invasive Bladder Carcinoma

Conditions: Official terms:
Urinary Bladder Neoplasms

Conditions: Keywords:
circulating tumor DNA
biospecimen
surgery
radiotherapy
chemotherapy
trimodality

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Prospective

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.

Criteria for eligibility:

Study pop:
University of North Carolina Patients

Sampling method: Non-Probability Sample
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Locations:

Facility:
Name: North Carolina Cancer Hospital (UNC)

Address:
City: Chapel Hill
Zip: 27599
Country: United States

Start date: January 10, 2023

Completion date: April 19, 2025

Lead sponsor:
Agency: UNC Lineberger Comprehensive Cancer Center
Agency class: Other

Source: UNC Lineberger Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05630131
http://unclineberger.org/patientcare/clinical-trials/clinical-trials