Clinical trial NCT05672615: Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
Official title: Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With Bacillus Calmete-Guerin
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Muscle Invasive Bladder Cancer
Keywords: Bacillus Calmette-Guerin
Mood Alterations
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects that are 18 years old or older who have pathologically confirmed non-muscle invasive bladder cancer. Subjects receiving intravesical treatments as part of their standard of care.

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.

Detailed description: Patients with Non-Muscle Invasive Bladder Cancer who are receiving intravesical treatments are eligible to participate in this study. Participants will be asked to complete the Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale prior to each induction intravesical treatment. During the 6-week induction intravesical treatment, participants will also be given a daily mood dairy to complete. Urine Specimens will be collected prior to each induction intravesical treatment and at each 3-month cystoscopy appointment during the treatment course. An at home urine collection may occur 6 hours post intravesical treatment. Research Blood Samples will be collected prior to the first induction intravesical treatment, prior to the fourth intravesical treatment, and prior to each 3-month follow-up cystoscopy as indicated by the participant's treatment course. Participants will be asked to complete the Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale prior to each 3-month follow-up cystoscopy during the treatment course. A 3-week daily mood diary will be completed by participants during the 3-week intravesical maintenance treatment. Participants will be given a daily mood diary to complete between the 3-month follow-up cystoscopy appointments.

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

Primary outcomes:
measure: Change in cytokine response as assessed by urine samples
timeFrame: Prior to each 6-week intravesical treatment and every 3-month Cystoscopy for 24 months
measure: Change in cytokine response as assessed by blood samples
timeFrame: Prior to the first intravesical treatment, prior to the fourth intravesical treatment, and prior to the each 3-month follow-up cystoscopy
measure: Screening for Mood Disorders utilizing the Zung Self Rating Depression Scale
timeFrame: Prior to each induction intravesical treatment for six weeks and each 3-month surveillance visit
Secondary outcomes:
measure: Screening for Mood Disorders utilizing the Zung Self Rating Anxiety Scale
timeFrame: Prior to each induction intravesical treatment for six weeks and each 3-month surveillance visit
measure: Screening for Mood Disorders utilizing daily mood diaries
timeFrame: Daily mood diary for 6-week induction intravesical treatment course, daily mood diary for 3-week intravesical treatment maintenance course, and daily mood diary between 3-month follow up cystoscopy appointments
measure: Evaluate DNA and RNA-based liquid biopsy biomarkers and correlate them with tissue response
timeFrame: Prior to the first intravesical treatment, prior to the fourth intravesical treatment, and prior to each 3-month follow-up cystoscopy
Other outcomes:
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
Study officials:
affiliation: Johns Hopkins University
name: Armine Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: