Recruiting

BCG

Sponsor:

Johns Hopkins University

Code:

NCT05672615

Conditions

Non-Muscle Invasive Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Questionnaires

Daily Mood Diaries

Urine Specimen Collection

Research Blood Draw

Utilize excess tissue from a standard of care procedure

Study Details

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.

Conditions

Non-Muscle Invasive Bladder Cancer

Study ID

NCT05672615

Start date

Mar 21, 2023

Status verified date

Nov, 2025

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

42 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Questionnaires

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.

Daily Mood Diaries

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 Specimen Collection

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.

Research Blood Draw

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.

Utilize excess tissue from a standard of care procedure

Participants may indicate permission to provide excess tissue from a clinically indicated procedure for research purposes.

Primary outcome measure

  • Change in cytokine response as assessed by urine samples [ Time Frame: Prior to each 6-week intravesical treatment and every 3-month Cystoscopy for 24 months ]
  • Change in cytokine response as assessed by blood samples [ Time Frame: 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 [ Time Frame: Prior to each induction intravesical treatment for six weeks and each 3-month surveillance visit ]

Central Contacts and Locations

Central contacts

Domani Rodriguez

2026605561drodri59@jh.edu

Armine Smith, MD

202-660-5561asmit165@jhmi.edu

Locations

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Domani Rodriguez

202-660-5561drodri59@jh.edu

Armine Smith, MD

202-660-5561asmit165@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Nov 18, 2025

Last verified

Nov, 2025

Keywords

  • Bacillus Calmette-Guerin
  • Mood Alterations

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-11-18.