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Mood Alterations in the Patients with Non-Muscle Invasive Bladder Cancer Treated with Bacillus Calmete-Guerin
Trial Status: active
This study evaluates mood disorders in patients undergoing treatment with Bacillus Calmete-Guerin for non-muscle invasive bladder cancer.
Inclusion Criteria
* Subjects with a pathologically confirmed non-muscle invasive bladder cancer
* Age ≥ 18 years old
* Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria
* Patients that are not candidates for intravesical treatment due to the nature of their disease, such as variant histology or progressive disease after a prior course of intravesical treatment
* Patients who are pregnant
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05672615.
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Contact: Armine K Smith
Phone: 202-660-5561
PRIMARY OBJECTIVES:
I. Collect urine and blood samples from the patients with non-muscle invasive bladder cancer who are undergoing intravesical instillations for cytokine response to treatment.
II. Screen for mood disorders in this patient population at baseline and while undergoing treatment.
III. Evaluate DNA and RNA-based liquid biopsy biomarkers and correlate them with the tissue response to therapy.
OUTLINE: This is an observational study.
Patients undergo blood and urine sample collection and complete questionnaires on study.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
