[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04968834":3,"trial-entities:NCT04968834":158,"trial-summary:NCT04968834":163},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":46,"minimum_age":25,"maximum_age":47,"healthy_volunteers":15,"eligibility_criteria":48,"std_ages":57,"locations":60,"central_contacts":148,"overall_officials":153,"references":156,"see_also_links":157},"NCT04968834","20-302","Genomically Profiling, Collecting, Archiving and Distributing Hematologic Malignancy Specimens","Protocol For Genomically Profiling, Collecting, Archiving and Distributing Blood and Bone Marrow Specimens From Children and Young Adults With Hematologic Malignancy","RECRUITING","2033-06","2026-07","2026-07-16","2021-06-11","Dana-Farber Cancer Institute","OTHER",false,"This research study is a genomic profiling and repository study for children and young adults who have leukemia, myelodysplastic syndrome (MDS) or myeloproliferative syndrome (MPS). Genes are the part of cells that contain the instructions which tell cells how to make the right proteins to grow and work. Genes are composed of DNA letters that spell out these instructions. Genomic profiling helps investigators understand why the disease develops and the instructions that led to its development. Understanding the genetic factors of the disease can also help investigator understand why the disease of some people can respond to certain therapies differently than others.\n\nThe genomic profiling will be performed using bone marrow and blood samples that either have already been obtained during a previous clinical procedure or will be obtained at the time of a scheduled clinical procedure. Studying the genetic information in the cells of these samples will provide information about the origin, progression, and treatment of leukemia and myeloproliferative syndromes and myelodysplastic syndrome. Storing the bone marrow and blood samples will allow for additional research and genomic assessments to be performed in the future.","Pediatric patients with new diagnosis or relapsed\u002Frefractory acute leukemia, MDS\u002FAML, chronic leukemia, myeloproliferative syndromes or myelodysplastic syndrome will be enrolled onto this study. At the time of enrollment, a sample of the leukemia will be submitted for genomic profiling using CLIA assay(s). This information will be returned to the treating oncologist. The study will collect follow up data on patient outcome and whether the genomic profiling influenced treatment.\n\nIt is expected that about 100 people each year will take part in this research study at 8 medical centers in the United States",[19,20,21],"Leukemia","Myelodysplastic Syndromes","Myeloproliferative Syndrome",[19,20,23],"Myeloproliferative syndrome (MPS)","OBSERVATIONAL",null,[],{"count":28,"type":29},300,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"GENETIC","Genomic profiling","Genomic profiling using CLIA assay",[36],"GENOMIC PROFILING AND SPECIMEN BANKING REGISTRATION ARM",[38],{"measure":39,"description":40,"timeFrame":41},"Number of Patients Enrolled for Genomic Profiling-Pediatric Leukemia","To perform genomic profiling of pediatric leukemia using clinical genomics platforms and return results to treating oncologist. This objective will be accomplished by enrolling patients and obtaining samples for sequencing and banking. The pathologist-interpreted genomic test results will be returned to the treating oncologist.","3 Years",[43],{"measure":44,"description":45,"timeFrame":41},"Number of Patients Enrolled for Genomic Profiling-New Diagnosis","To collect and bank samples from pediatric patients with new diagnosis or relapsed\u002Frefractory acute and chronic leukemia, and myelodysplastic syndrome. This objective will be accomplished by enrolling patients and obtaining samples for sequencing and banking.","ALL","30 Years",{"inclusion":49,"exclusion":55,"raw_text":56},[50,51,52,53,54],"Age: birth to \\\u003C 30 years of age","Diagnosis:","Pathology Criteria:","Specimen Criteria:","Sufficient sample available for genomic profiling OR bone marrow aspirate\u002Fblood draw planned for clinical care which is anticipated to allow collection of minimum specimen for testing (See Section 6.1 for description of specimen requirements)",[],"Inclusion Criteria:\n\n* Age: birth to \\\u003C 30 years of age\n* Diagnosis:\n\n  \\-- Patient with acute leukemia, chronic leukemia, MDS\u002FAML, myelodysplastic syndrome or myeloproliferative syndromes. Disease can be newly diagnosed or relapsed\u002Frefractory.\n* Pathology Criteria:\n\n  \\-- Histologic confirmation of leukemia or myelodysplastic syndrome (MDS) or myeloproliferative syndrome (MPS) at the time of diagnosis or recurrence\n* Specimen Criteria:\n\n  * Sufficient sample available for genomic profiling OR bone marrow aspirate\u002Fblood draw planned for clinical care which is anticipated to allow collection of minimum specimen for testing (See Section 6.1 for description of specimen requirements)\n\nExclusion Criteria:\n\n\\- Insufficient leukemia or MDS specimen available for profiling from diagnosis or recurrence (See Section 6.1); or bone marrow evaluations NOT planned for clinical care; or peripheral blast percentage \\\u003C20%, or clinical blood draw not planned",[58,59],"CHILD","ADULT",[61,75,87,96,100,112,124,136],{"facility":62,"status":8,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":72},"Connecticut Children's Medical Center","Hartford","Connecticut","06106","United States",[68],{"name":69,"role":70,"email":71},"Natalie Bezler, MD","CONTACT","Nbezler@connecticutchildrens.org",{"lat":73,"lon":74},41.76371,-72.68509,{"facility":76,"status":8,"city":77,"state":78,"zip":79,"country":66,"contacts":80,"geoPoint":84},"Maine Medical Center","Portland","Maine","04102",[81],{"name":82,"role":70,"email":83},"Sei Sze, MD","Sei.Sze@mainehealth.org",{"lat":85,"lon":86},43.65737,-70.2589,{"facility":88,"status":89,"city":90,"state":91,"zip":92,"country":66,"geoPoint":93},"Boston Children's Hospital","ACTIVE_NOT_RECRUITING","Boston","Massachusetts","02115",{"lat":94,"lon":95},42.35843,-71.05977,{"facility":97,"status":89,"city":90,"state":91,"zip":98,"country":66,"geoPoint":99},"Dana Farber Cancer Institute","02215",{"lat":94,"lon":95},{"facility":101,"status":8,"city":102,"state":103,"zip":104,"country":66,"contacts":105,"geoPoint":109},"Dartmouth-Hitchcock","Lebanon","New Hampshire","03756",[106],{"name":107,"role":70,"email":108},"Angela Ricci, MD","angela.m.ricci@hitchcock.org",{"lat":110,"lon":111},43.64229,-72.25176,{"facility":113,"status":8,"city":114,"state":115,"zip":116,"country":66,"contacts":117,"geoPoint":121},"Albany Medical Center","Albany","New York","12208",[118],{"name":119,"role":70,"email":120},"Jessica Geaney, MD","geaneyj@amc.edu",{"lat":122,"lon":123},42.65258,-73.75623,{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":66,"contacts":129,"geoPoint":133},"Lifespan Cancer Institute","Providence","Rhode Island","02903",[130],{"name":131,"role":70,"email":132},"Jennifer Welch, MD","jwelch@lifespan.org",{"lat":134,"lon":135},41.82399,-71.41283,{"facility":137,"status":8,"city":138,"state":139,"zip":140,"country":66,"contacts":141,"geoPoint":145},"University of Vermont Medical Center","Burlington","Vermont","05401",[142],{"name":143,"role":70,"email":144},"Jessica Heath, MD","Jessica.Heath@uvmhealth.org",{"lat":146,"lon":147},44.47588,-73.21207,[149],{"name":150,"role":70,"phone":151,"email":152},"Yana Pikman, MD","(617) 632-4754","yana_pikman@dfci.harvard.edu",[154],{"name":150,"affiliation":13,"role":155},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":159,"biomarkers":162},[19,160,161],"Myelodysplastic Syndrome","Myeloproliferative syndrome",[],{"nct_id":4,"found":164,"summary":165,"prompt_version":175},true,{"design":166,"status":167,"heading":168,"summary":169,"follow_up":170,"word_count":171,"commitments":172,"compensation":173,"drugs_mentioned":174},"This is an observational study, meaning researchers will collect information without giving new treatments. It plans to enroll 300 participants.","completed","Genomic Profiling for Pediatric Leukemia and Related Blood Cancers","This study is looking at the genes of children and young adults (up to age 30) who have leukemia, myelodysplastic syndromes (MDS), or myeloproliferative syndromes (MPS). Genes are like instructions that tell cells how to grow and work. By using \"genomic profiling\" (a test that looks at these instructions), researchers hope to understand why these diseases develop and why some people respond to treatments differently. This study aims to enroll 300 participants. The main goal is to see how many children with leukemia are enrolled for genomic profiling over three years. The study status is currently unclear, so it's not known if they are actively recruiting.","The study will collect follow-up data on patient outcome and whether genomic profiling influenced treatment, but a specific duration is not mentioned.",106,"A sample of your leukemia will be submitted for genomic profiling. The study will also collect follow-up data on your health and how the genomic profiling affected your treatment.","Not stated in the trial record.",[33],"v2"]