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Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG

NCT05672615 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2025-11-18

No results posted yet for this study

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

Interventions

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

Principal Investigators

  • Armine Smith, MD · Johns Hopkins University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2027-03-31
Completion
2028-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05672615 on ClinicalTrials.gov