[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490937":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":43,"centralContacts":47,"locations":56,"responsibleParty":74,"collaborators":10,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":10,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":10,"enrollmentInfo":85,"targetDuration":10,"studyType":88,"phases":10,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-Muscle Invasive Bladder Cancer - Bacillus Calmete-Guerin (BCG) intravesical treatments",null,"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.",[13,14,15,16,17],"Other: Questionnaires","Other: Daily Mood Diaries","Other: Urine Specimen Collection","Other: Research Blood Draw","Other: Utilize excess tissue from a standard of care procedure",{"label":19,"type":10,"description":20,"interventionNames":21},"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.",[13,14,15,16,17],[23,27,31,35,39],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"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.",[9,19],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"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.",[9,19],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"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.",[9,19],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"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.",[9,19],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":10},"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.",[9,19],[44],{"name":45,"affiliation":5,"role":46},"Armine Smith, MD","PRINCIPAL_INVESTIGATOR",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":10,"email":52},"Domani Rodriguez","CONTACT","2026605561","drodri59@jh.edu",{"name":45,"role":50,"phone":54,"phoneExt":10,"email":55},"202-660-5561","asmit165@jhmi.edu",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Sibley Memorial Hospital","RECRUITING","Washington D.C.","District of Columbia","20016","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-77.03637,38.89511,{"lat":69,"lon":68},[72,73],{"name":49,"role":50,"phone":54,"phoneExt":10,"email":52},{"name":45,"role":50,"phone":54,"phoneExt":10,"email":55},{"type":75,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100490937","mood-alterations-in-the-patients-with-non-muscle-invasive-bladder-cancer-treated-with-bcg-100490937",false,"NCT05672615","Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG","Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With Bacillus Calmete-Guerin","Inclusion Criteria:\n\n* Subjects with a pathologically confirmed non-muscle invasive bladder cancer\n* Age ≥ 18 years old\n* Ability to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* 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.\n* Patients who are pregnant","ALL","18 Years",{"count":86,"type":87},42,"ESTIMATED","OBSERVATIONAL","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.",[91],"Non-Muscle Invasive Bladder Cancer",[93,94],"Bacillus Calmette-Guerin","Mood Alterations","2025-11-17",{"date":97,"type":98},"2025-11-18","ACTUAL",{"date":100,"type":98},"2023-03-21",{"date":102,"type":87},"2028-03",{"name":5,"class":6},1]