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Mood Changes in Bladder Cancer Patients Receiving BCG Treatment

This study is looking at how mood changes in people with non-muscle invasive bladder cancer who are being treated with intravesical Bacillus Calmette-Guerin (BCG). This treatment involves placing the BCG directly into the bladder. You may be able to join if you have this type of bladder cancer and are receiving BCG. The study will ask you to complete questionnaires and daily mood diaries. Researchers will also collect blood and urine samples, and may use extra tissue from a standard procedure. The main goal is to see how your mood and certain body responses (cytokines) change during treatment over 24 months. The study is currently unclear on its recruitment status and plans to enroll 42 participants.

Study design
This is an observational study involving 42 participants. It is not specified if it's randomized or blinded.
What's involved
You would complete questionnaires and daily mood diaries. You would also provide blood and urine samples before and during treatment, and at follow-up appointments.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in cytokine response for 24 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05672615

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

Recruiting
Not specifiedAges 18+Observational
Johns Hopkins University
~42 participants
Updated 2025-11-18 on ClinicalTrials.gov
What's tested:QuestionnairesDaily Mood DiariesUrine Specimen CollectionResearch Blood DrawUtilize excess tissue from a standard of care procedure

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in cytokine response as assessed by urine samples
Measured over Prior to each 6-week intravesical treatment and every 3-month Cystoscopy for 24 months
+2 more outcomes measured

Conditions

Non-Muscle Invasive Bladder Cancer

Explore related trials

Bladder Carcinoma

NCT05672615

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Sibley Memorial Hospital

    Washington D.C., District of Columbiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Armine Smith, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Domani Rodriguez
[email protected]
2026605561
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in cytokine response as assessed by urine samplesPrior to each 6-week intravesical treatment and every 3-month Cystoscopy for 24 months

    Collect urine samples from the patients with non-muscle invasive bladder cancer who are undergoing intravesical instillations for cytokine response to treatment

  • Change in cytokine response as assessed by blood samplesPrior to the first intravesical treatment, prior to the fourth intravesical treatment, and prior to the each 3-month follow-up cystoscopy

    Collect blood samples from the patients with non-muscle invasive bladder cancer who are undergoing intravesical instillations for cytokine response to treatment

  • Screening for Mood Disorders utilizing the Zung Self Rating Depression ScalePrior to each induction intravesical treatment for six weeks and each 3-month surveillance visit

    Screen for mood disorders in patients diagnosed with Non-muscle Invasive Bladder Cancer at baseline and while undergoing treatment utilizing the Zung Self Rating Depression Scale. The Zung Self-Rating Depression Scale has the following score ranges: Normal Range (25-49), Mildly Depressed (50-59), Moderately Depressed (60-69), Severely Depressed (70 and above)