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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-10

Study Completion Date

2025-08-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Urine-DNA Biomarkers in Detecting Bladder Cancer

NCT03066310

Bladder Cancer Biomarker Diagnosis +1 more

COMPLETED

ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer

NCT07151118

Biliary Tract Cancer

NOT_YET_RECRUITING

Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors

NCT04354064

Healthy Volunteer Prostate Cancer Head and Neck Cancer +10 more

RECRUITING

Genetic Susceptibility to Tumor Recurrence and Progression in Patients With Non-Muscle Invasive Bladder Cancer

NCT00582387

Bladder Cancer Urinary Cancer Nonmuscle Invasive Bladder Cancer

COMPLETED

Circulating Tumor DNA Exposure in Peripheral Blood

NCT03517332

Colorectal Cancer Pancreatic Adenocarcinoma Gastric Cancer +8 more

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder Cancer Muscle-Invasive Bladder Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.