Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment42 (estimated)
SponsorJohns Hopkins University
Academic / other
Locations1 site (Washington D.C., District of Columbia)
StatusRecruiting
StartedMarch 21, 2023
Main results expectedMarch 2027
Study endsMarch 2028
Registry record updatedNovember 4, 2026
Trial IDNCT05672615 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

  • 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.