Evaluating mood changes in bladder cancer patients treated with BCG
Official title: Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With Bacillus Calmete-Guerin
Run by Johns Hopkins University · NCT05672615 · Data updated 2026-11-12
This study is trying to see how BCG treatment for bladder cancer affects the mood of patients by tracking their anxiety and depression levels during the therapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Status | Recruiting |
| Started | March 21, 2023 |
| Main results expected | March 2027 |
| Study ends | March 2028 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT05672615 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with pathologically confirmed Non-Muscle Invasive Bladder Cancer who are eligible for intravesical treatment.
✕Probably not a fit
Patients who are not candidates for intravesical treatment or those who are pregnant may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess mood alterations in patients with Non-Muscle Invasive Bladder Cancer undergoing intravesical Bacillus Calmette-Guerin (BCG) treatment. Participants will provide blood and urine samples, complete questionnaires, and maintain daily mood diaries throughout their treatment course. The study will track changes in anxiety and depression levels using standardized scales before and during treatment. Data collected will help understand the psychological impact of BCG therapy on these patients.
Why it matters
Potential benefit: If successful, this study could provide insights into the psychological effects of BCG treatment, potentially leading to better support and management strategies for patients.
How similar studies have gone: While studies on mood alterations in cancer patients exist, this specific approach focusing on BCG treatment in bladder cancer is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Sibley Memorial Hospital
Washington D.C., District of Columbia, United States Recruiting
Study contacts
- Principal investigator: Armine Smith, MD — Johns Hopkins University
- Study coordinator: Domani Rodriguez
- Email: drodri59@jh.edu
- Phone: 2026605561
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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NMIBC sample collection to test cancer monitoring biomarkers
This study tests a blood, urine, and tumor tissue collection approach in people with high-risk non-muscle invasive bladder cancer to see if a molecular test can detect residual disease and monitor recurrence.
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Sequential Gemcitabine Plus Docetaxel vs Gemcitabine Plus Mitomycin C for BCG-Unresponsive NMIBC
This study tests whether adding docetaxel after gemcitabine is better or worse than adding mitomycin C after gemcitabine for people with BCG-unresponsive high-grade non-muscle-invasive bladder cancer.
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Is ongoing systemic immunotherapy needed after achieving tumor-free status in very-high-risk NMIBC?
This study tests whether patients who have become tumor-free after a systemic immunotherapy-based bladder-sparing treatment can safely stop therapy and instead be watched closely.
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Comparing CT and MRI with VI-RADS for Bladder Cancer Staging
This study tests how well CT and MRI with VI-RADS can correctly stage bladder cancer before surgery in adults.
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How bladder microbes and immune signals affect lower urinary tract health
This project will test whether differences in bladder microbes and immune signals are linked to urinary tract health in adults with and without various urinary conditions.
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Cretostimogene for BCG‑unresponsive high‑grade non‑muscle‑invasive bladder cancer
This treatment will test cretostimogene plus n‑dodecyl‑β‑D‑maltoside in adults whose high‑grade non‑muscle‑invasive bladder cancer did not respond to BCG (carcinoma in situ with or without Ta/T1 tumors).
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.