[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100409784":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":55,"collaborators":10,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":10,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":10,"enrollmentInfo":67,"targetDuration":10,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants being treated with immunotherapy",null,"Participants who are to receive standard of care immunotherapy targeting PD-1 or PDL1 as treatment for malignancy",[13,14],"Other: blood draw and questionnaire completion","Other: questionnaire completion, blood collection",[16,20],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"blood draw and questionnaire completion","questionaires provided to subjects during visits while on study and baseline one tube of blood drawn",[9],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"questionnaire completion, blood collection","questionnaire provided to subject during study visits. One tube blood collected for research purposes at baseline",[9],[25],{"name":26,"affiliation":27,"role":28},"Philip Friedlander, MD PhD","MOUNT SINAI HOSPITAL","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":10,"email":33},"CONTACT","2128248588","philip.friedlander@mssm.edu",{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},"Emily Gallagher, MD","2122413422","emilygallagher@mssm.edu",[39],{"facility":40,"status":41,"city":42,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Mount Sinai Hospital \u002FTisch Cancer Cancer\u002FRuttenberg Treatment Center","RECRUITING","New York","10029","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-74.00597,40.71427,{"lat":50,"lon":49},[53,54],{"name":26,"role":31,"phone":32,"phoneExt":10,"email":33},{"name":26,"role":28,"phone":10,"phoneExt":10,"email":10},{"type":28,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Philip Friedlander","Assistant Professor","100409784","correlation-vitamin-d-level-to-endocrine-autoimmune-toxicity-due-to-immune-checkpoint-inhibitors-100409784",false,"NCT04615988","Correlation Vitamin D Level to Endocrine Autoimmune Toxicity Due to Immune Checkpoint Inhibitors","Correlation of Serum Vitamin D Level With the Development of Endocrine Autoimmune Complications During Treatment With Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n* Malignancy which the treating oncologist plans for next treatment to inhibit PD-1or PD-L1 with the immune inhibitor being the only immunotherapy. Twenty-five subjects in a separate cohort will need for eligibility to be planned for treatment with anti-PD1\u002FPD-L1 plus antri-CTLA-4 therapy.\n* Willingness to complete symptom questionnaires\n* Willingness to allow blood draws\n* Ability to provide informed consent\n* Age \\> 18 years old\n\nExclusion Criteria:\n\n* History of clinical or subclinical hyperthyroidism or hypothyroidism\n* Hemoglobin \\\u003C 9\n* Inability to come for all study visits.\n* Actively on vitamin D supplementation due to vitamin D deficiency (As part of a multivitamin is not exclusionary)\n* Pregnant or lactating\n* History of hypophysitis","ALL","18 Years",{"count":68,"type":69},17,"ESTIMATED","OBSERVATIONAL","The purpose of this research study is to see if the amount of vitamin D in ones blood makes it more or less likely to develop thyroid gland toxicity when being treated with immunotherapy that blocks the activity of proteins called programed death-1(PD-1) or programmed death ligand-1 (PD-L1). Immunotherapy is treatment that makes changes to the immune system to try to fight cancer. Immunotherapy treatments that block the activity of important parts of the immune system called PD-1 and PD-L1 are used to standardly treat many different types of cancer and can cause thyroid toxicity in certain people. In this study the treatment for your cancer is not research treatment but standard of care determined by your oncologist. Blood will be drawn before starting treatment to determine the amount of Vitamin D and also to assess thyroid function. Also questionnaires will be completed before starting treatment and while on treatment to assess symptoms you are experiencing.",[73,74,75],"Thyroid","PD-1","Cancer",[77,78,79],"vitamin D deficiency","immunotherapy with inhibitor of PD-1\u002FL1","immune mediated thyroid toxicity","2026-03-23",{"date":82,"type":83},"2026-03-27","ACTUAL",{"date":85,"type":83},"2021-06-09",{"date":87,"type":69},"2028-06",{"name":5,"class":6},1]