Non-Muscle Invasive Bladder CancerNCT05672615
Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
An observational study of Non-Muscle Invasive Bladder Cancer, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Muscle Invasive Bladder Cancer
- What is being tested?
- Questionnaires, Daily Mood Diaries and Urine Specimen Collection
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2023to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Domani Rodriguez, 202-660-5561, drodri59@jh.edu
Armine Smith, MD, 202-660-5561, asmit165@jhmi.edu
About this study
Official title: Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With Bacillus Calmete-Guerin
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.
Read the 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.
- Conditions
- Non-Muscle Invasive Bladder Cancer
- Being tested
- Questionnaires, Daily Mood Diaries, Urine Specimen Collection, Research Blood Draw, Utilize excess tissue from a standard of care procedure
- Keywords
- Bacillus Calmette-Guerin, Mood Alterations
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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 DiariesOther
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 CollectionOther
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 DrawOther
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 procedureOther
Participants may indicate permission to provide excess tissue from a clinically indicated procedure for research purposes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaires; Other: Daily Mood Diaries; Other: Urine Specimen Collection; Other: Research Blood Draw; Other: Utilize excess tissue from a standard of care procedure | |
| 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. Receives: Other: Questionnaires; Other: Daily Mood Diaries; Other: Urine Specimen Collection; Other: Research Blood Draw; Other: Utilize excess tissue from a standard of care procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cytokine response as assessed by urine samples
Collect urine samples from the patients with non-muscle invasive bladder cancer who are undergoing intravesical instillations for cytokine response to treatment
Measured: Prior to each 6-week intravesical treatment and every 3-month Cystoscopy for 24 months
Change in cytokine response as assessed by blood samples
Collect blood samples from the patients with non-muscle invasive bladder cancer who are undergoing intravesical instillations for cytokine response to treatment
Measured: 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
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)
Measured: Prior to each induction intravesical treatment for six weeks and each 3-month surveillance visit
Secondary outcomes (3)
Screening for Mood Disorders utilizing the Zung Self Rating Anxiety Scale
Screen for mood disorders in patients diagnosed with Non-muscle Invasive Bladder Cancer at baseline and while undergoing treatment utilizing the Zung Self Rating Anxiety Scale
Measured: Prior to each induction intravesical treatment for six weeks and each 3-month surveillance visit
Screening for Mood Disorders utilizing daily mood diaries
Screening for Mood Disorders at baseline and through the treatment course with daily mood diaries
Measured: 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
Evaluate DNA and RNA-based liquid biopsy biomarkers and correlate them with tissue response
Collect blood and urine samples from the patients with non-muscle invasive bladder cancer who are undergoing intravesical instillations and compare them with excess tissue from a clinically indicated procedure
Measured: Prior to the first intravesical treatment, prior to the fourth intravesical treatment, and prior to each 3-month follow-up cystoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start21 Mar 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armine Smith, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672615
- Sponsor's protocol ID
- IRB00306420
- Status last verified
- Nov 2026
- First submitted
- 3 Jan 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With Bacillus Calmete-Guerin
- ClinicalTrials.gov ID
- NCT05672615
- Acronym / sponsor ID
- IRB00306420
- Conditions
- Non-Muscle Invasive Bladder Cancer
- Keywords
- Bacillus Calmette-Guerin, Mood Alterations
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Muscle Invasive Bladder Cancer - Bacillus Calmete-Guerin (BCG) intravesical treatments | – | Other: Questionnaires, Other: Daily Mood Diaries, Other: Urine Specimen Collection, Other: Research Blood Draw, Other: Utilize excess tissue from a standard of care procedureParticipants 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 | – | Other: Questionnaires, Other: Daily Mood Diaries, Other: Urine Specimen Collection, Other: Research Blood Draw, Other: Utilize excess tissue from a standard of care procedureParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesParticipants 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 | Non-Muscle Invasive Bladder Cancer - Bacillus Calmete-Guerin (BCG) intravesical treatments, Non-Muscle Invasive Bladder Cancer - Chemotherapy intravesical treatments |
| Daily Mood DiariesParticipants 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 | Non-Muscle Invasive Bladder Cancer - Bacillus Calmete-Guerin (BCG) intravesical treatments, Non-Muscle Invasive Bladder Cancer - Chemotherapy intravesical treatments |
| Urine Specimen CollectionUrine 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 | Non-Muscle Invasive Bladder Cancer - Bacillus Calmete-Guerin (BCG) intravesical treatments, Non-Muscle Invasive Bladder Cancer - Chemotherapy intravesical treatments |
| Research Blood DrawBlood 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 | Non-Muscle Invasive Bladder Cancer - Bacillus Calmete-Guerin (BCG) intravesical treatments, Non-Muscle Invasive Bladder Cancer - Chemotherapy intravesical treatments |
| Utilize excess tissue from a standard of care procedureParticipants may indicate permission to provide excess tissue from a clinically indicated procedure for research purposes. | Other | Non-Muscle Invasive Bladder Cancer - Bacillus Calmete-Guerin (BCG) intravesical treatments, Non-Muscle Invasive Bladder Cancer - Chemotherapy intravesical treatments |
Primary outcome
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
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 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
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 Scale
Time frame: Prior 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)
3 secondary outcomes
Screening for Mood Disorders utilizing the Zung Self Rating Anxiety Scale
Time frame: Prior to each induction intravesical treatment for six weeks and each 3-month surveillance visit
Screening for Mood Disorders utilizing daily mood diaries
Time frame: 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
Evaluate DNA and RNA-based liquid biopsy biomarkers and correlate them with tissue response
Time frame: Prior to the first intravesical treatment, prior to the fourth intravesical treatment, and prior to each 3-month follow-up cystoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Armine Smith, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Muscle Invasive Bladder Cancer, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Domani Rodriguez (2026605561, drodri59@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.