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Recruiting NCT05672615

NCT05672615 Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG

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Clinical Trial Summary
NCT ID NCT05672615
Status Recruiting
Phase
Sponsor Johns Hopkins University
Condition Non-Muscle Invasive Bladder Cancer
Study Type OBSERVATIONAL
Enrollment 42 participants
Start Date 2023-03-21
Primary Completion 2027-03

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
QuestionnairesDaily Mood DiariesUrine Specimen Collection

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 42 participants in total. It began in 2023-03-21 with a primary completion date of 2027-03.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility 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

Contact & Investigator

Central Contact

Domani Rodriguez

✉ drodri59@jh.edu

📞 2026605561

Principal Investigator

Armine Smith, MD

PRINCIPAL INVESTIGATOR

Johns Hopkins University

Frequently Asked Questions

Who can join the NCT05672615 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Muscle Invasive Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05672615 currently recruiting?

Yes, NCT05672615 is actively recruiting participants. Contact the research team at drodri59@jh.edu for enrollment information.

Where is the NCT05672615 trial being conducted?

This trial is being conducted at Washington D.C., United States.

Who is sponsoring the NCT05672615 clinical trial?

NCT05672615 is sponsored by Johns Hopkins University. The principal investigator is Armine Smith, MD at Johns Hopkins University. The trial plans to enroll 42 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology