[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06116032":3,"trial-entities:NCT06116032":86,"trial-summary:NCT06116032":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":24,"primary_purpose":16,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":38,"secondary_outcomes":43,"sex":44,"minimum_age":45,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":46,"std_ages":55,"locations":58,"central_contacts":76,"overall_officials":81,"references":84,"see_also_links":85},"NCT06116032","Study02001227","Immune Profiling for Cancer Immunotherapy Response","RECRUITING","2029-01-01","2025-12","2025-12-16","2022-10-03","Dartmouth-Hitchcock Medical Center","OTHER",false,"In patients clinically treated with FDA-approved immunotherapy the investigators will assess the predictive value of pre- and on-treatment 1) immune-methylation profiling across cancer types, and 2) immune-methylation profiling and cytokine profiling within cancer types.",null,[18,19,20,21],"Cancer","Tumor, Solid","Hematologic Malignancy","Blood Cancer",[23],"Immunotherapy","OBSERVATIONAL",[],{"count":27,"type":28},1500,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DIAGNOSTIC_TEST","Methylation Cytometry","Assessment of the ability of Methylation Cytometry in pre-treatment peripheral blood and in repeated measures over the duration of treatment to predict treatment response or occurrence of adverse events.",[35,36,37],"Bone Marrow Transplant","CAR T","Standard of Care Checkpoint",[39],{"measure":40,"description":41,"timeFrame":42},"Response to therapy","The investigators will employ iRECIST, and outcome criteria will be clinically evaluated and include the primary endpoints of progression (non-responders) or response, with patients followed up every month for 6 months (or until death, loss to follow-up, or withdrawal of consent), judged according to the objective response rate (ORR) assessed using iRECIST.","5 years",[],"ALL","18 Years",{"inclusion":47,"exclusion":50,"raw_text":54},[48,49],"Cancer patients receiving or will receive immunotherapy under FDA- approved indication (e.g. checkpoint inhibitor therapy with pembrolizumab, nivolumab, or ipilimumab, or cellular immunotherapy).","Participants are eligible regardless of the type of prior therapy (i.e. prior immunotherapy treated participants can be included).",[51,52,53],"Pregnant women\u002Ffetuses\u002Fneonates","Prisoners","Decision-impaired individuals","Inclusion Criteria:\n\n* Cancer patients receiving or will receive immunotherapy under FDA- approved indication (e.g. checkpoint inhibitor therapy with pembrolizumab, nivolumab, or ipilimumab, or cellular immunotherapy).\n* Participants are eligible regardless of the type of prior therapy (i.e. prior immunotherapy treated participants can be included).\n\nExclusion Criteria:\n\n* Pregnant women\u002Ffetuses\u002Fneonates\n* Prisoners\n* Decision-impaired individuals",[56,57],"ADULT","OLDER_ADULT",[59],{"facility":12,"status":7,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":73},"Lebanon","New Hampshire","03756","United States",[65,70],{"name":66,"role":67,"phone":68,"email":69},"Hannah G Stolrow, BA","CONTACT","7205174950","hannah.stolrow@dartmouth.edu",{"name":71,"role":72},"Brock C Christensen, PhD","PRINCIPAL_INVESTIGATOR",{"lat":74,"lon":75},43.64229,-72.25176,[77,80],{"name":71,"role":67,"phone":78,"email":79},"603-650-1827","brock.c.christensen@dartmouth.edu",{"name":66,"role":67,"phone":68,"email":69},[82],{"name":71,"affiliation":83,"role":72},"Dartmouth College",[],[],{"nct_id":4,"conditions":87,"biomarkers":90},[88,89],"Hematologic Neoplasm","Solid Neoplasm",[],{"nct_id":4,"found":92,"summary":93,"prompt_version":102},true,{"design":94,"status":95,"heading":6,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This is an observational study planning to enroll 1500 participants. It is not a treatment study, but rather looks at information from patients already receiving immunotherapy.","completed","This observational study is looking at how your immune system responds to cancer immunotherapy, specifically treatments like pembrolizumab, nivolumab, or ipilimumab. Researchers will collect blood samples before and during your treatment to see if certain immune markers (immune-methylation profiling and cytokine profiling) can predict how well you respond to therapy or if you experience side effects. You can join if you are an adult (18 years or older) with cancer who is receiving or will receive FDA-approved immunotherapy. The study aims to understand treatment response over 5 years. The current recruitment status is unclear.","Your response to therapy will be measured for 5 years.",94,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]