Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
1 other identifier
observational
42
1 country
1
Brief Summary
The purpose of this study is to evaluate mood changes in patients with Non-Muscle Invasive Bladder Cancer who are receiving intravesical Bacillus Calmete-Guerin (BCG). Patients with Non-Muscle Invasive Bladder Cancer receiving intravesical treatments are eligible to participate in this study. Participation involves providing research blood and urine samples prior to the start of treatment and throughout the treatment course. The study team will also collect participant's medical history and clinical information. Participants will be asked to complete questionnaires and daily mood diaries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2023
CompletedStudy Start
First participant enrolled
March 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
November 18, 2025
November 1, 2025
3.9 years
January 3, 2023
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in cytokine response as assessed by urine samples
Collect urine samples from the patients with non-muscle invasive bladder cancer who are undergoing intravesical instillations for cytokine response to treatment
Prior to each 6-week intravesical treatment and every 3-month Cystoscopy for 24 months
Change in cytokine response as assessed by blood samples
Collect blood samples from the patients with non-muscle invasive bladder cancer who are undergoing intravesical instillations for cytokine response to treatment
Prior to the first intravesical treatment, prior to the fourth intravesical treatment, and prior to the each 3-month follow-up cystoscopy
Screening for Mood Disorders utilizing the Zung Self Rating Depression Scale
Screen for mood disorders in patients diagnosed with Non-muscle Invasive Bladder Cancer at baseline and while undergoing treatment utilizing the Zung Self Rating Depression Scale. The Zung Self-Rating Depression Scale has the following score ranges: Normal Range (25-49), Mildly Depressed (50-59), Moderately Depressed (60-69), Severely Depressed (70 and above)
Prior to each induction intravesical treatment for six weeks and each 3-month surveillance visit
Secondary Outcomes (3)
Screening for Mood Disorders utilizing the Zung Self Rating Anxiety Scale
Prior to each induction intravesical treatment for six weeks and each 3-month surveillance visit
Screening for Mood Disorders utilizing daily mood diaries
Daily mood diary for 6-week induction intravesical treatment course, daily mood diary for 3-week intravesical treatment maintenance course, and daily mood diary between 3-month follow up cystoscopy appointments
Evaluate DNA and RNA-based liquid biopsy biomarkers and correlate them with tissue response
Prior to the first intravesical treatment, prior to the fourth intravesical treatment, and prior to each 3-month follow-up cystoscopy
Study Arms (2)
Non-Muscle Invasive Bladder Cancer - Bacillus Calmete-Guerin (BCG) intravesical treatments
Participants who are receiving BCG intravesical treatments will be asked to provide research urine samples and blood samples prior to and during their treatment course. Participants will also be asked to complete the Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale at the start and throughout the treatment course. Participants will be given a daily mood diary to complete at the following timepoints: 6-week induction treatment, 3-week maintenance treatment, and the 3-month follow-up. The study team will ask permission from participants to utilize excess tissue samples from standard of care procedures and biopsies. Participants' medical history and clinical data will also be collected for the study.
Non-Muscle Invasive Bladder Cancer - Chemotherapy intravesical treatments
Participants who are receiving chemotherapy intravesical treatments will be asked to provide research urine samples and blood samples prior to and during their treatment course. Participants will also be asked to complete the Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale at the start and throughout the treatment course. Participants will be given a daily mood diary to complete at the following timepoints: 6-week induction treatment, 3-week maintenance treatment, and the 3-month follow-up. The study team will ask permission from participants to utilize excess tissue samples from standard of care procedures and biopsies. Participants' medical history and clinical data will also be collected for the study.
Interventions
Participants will be given the Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale to complete prior to each induction intravesical treatment and prior to 3-month follow-up appointments.
Participants will be given daily mood diaries to complete during their 6-week induction intravesical treatment, 3-week maintenance treatment course, and between 3-month follow-up appointments.
Urine collections from patients will occur prior to each induction intravesical treatment and at 3-month follow-up cystoscopy appointments. An at home urine collection may occur 6 hours post intravesical treatment.
Blood collections will occur prior to first intravesical treatment, prior to fourth intravesical treatment, and each 3-month cystoscopy as indicated by the participant's treatment course.
Participants may indicate permission to provide excess tissue from a clinically indicated procedure for research purposes.
Eligibility Criteria
Subjects that are 18 years old or older who have pathologically confirmed non-muscle invasive bladder cancer. Subjects receiving intravesical treatments as part of their standard of care.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Biospecimen
Participants will be asked for research blood and urine samples prior to the start of treatment and throughout the treatment course. The study team will also ask participants permission to utilize excess tissue from standard of care procedures.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Armine Smith, MD
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2023
First Posted
January 5, 2023
Study Start
March 21, 2023
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
November 18, 2025
Record last verified: 2025-11