[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100249818":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":61,"centralContacts":65,"locations":70,"responsibleParty":87,"collaborators":10,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":10,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":10,"maxAge":10,"enrollmentInfo":97,"targetDuration":10,"studyType":100,"phases":10,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":72,"whyStopped":10,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"St. Jude Children's Research Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants",null,"St. Jude patients with a diagnosed solid or liquid tumor (benign or malignant) and their biological parents or legally authorized representative.\n\nInterventions: Study Introduction Visit, Informed Consent Visit, Informed Consent Follow-Up Visit, Return of Results Conversation, two Return of Results Follow-Up Visits, Tissue Sample (when available), Blood Sample or Skin Biopsy.",[13,14,15,16,17,18,19],"Other: Study Introduction Visit","Other: Informed Consent Visit","Other: Informed Consent Follow-Up Visit","Other: Return of Results Conversation","Other: Return of Results Follow-Up Visits","Procedure: Blood Sample","Procedure: Skin Biopsy",[21,25,32,38,43,48,55],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"Study Introduction Visit","Within 5±3 weeks following arrival at SJCRH, or at the participant\u002Ffamily's convenience, participants will meet with a genetic counselor and clinician, provide information for a family pedigree, undergo a physical and discuss germline testing options. Study introduction materials will be provided. Families interested in the G4K study will be referred to the study nurse or other G4K member and an Informed consent visit will be scheduled.",[9],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Informed Consent Visit","Within 1±3 weeks following the Study Introduction Visit, or at the participant\u002Ffamily's convenience, the research nurse or other study team member will consent the family and collect demographic and medical information. Participants will complete assessment questionnaires.",[9],[30,31],"Demographic and Medical forms","Questionnaires",{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Informed Consent Follow-Up Visit","At or after enrollment but before the release of the gerline results, or at the participant\u002Ffamily's convenience, a subset of participants (30-40) will participate in semi-structured interviews.",[9],[37],"Interviews",{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Return of Results Conversation","Participants will complete the assessment questionnaires.",[9],[31,37],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Return of Results Follow-Up Visits","Return of Results Follow-Up Visits will be conducted twice: the first within 8±4 weeks of the Return of Results Conversation, or at the participant\u002Ffamily's convenience, and the second within 28 ± 4 weeks of the Return of Results Conversation or at the participant\u002Ffamily's convenience. At each visit, participants will complete assessment questionnaires. Semi-structured interviews with parents and adolescents will be conducted.",[9],[31,37],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"PROCEDURE","Blood Sample","For patients who have not previously provided a blood sample, a sample of blood will be obtained as a source of germline DNA.",[9],[54],"Phlebotomy",{"type":49,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Skin Biopsy","After consent, for participants with a diagnosis where peripheral blood is likely to be contaminated by tumor cells, skin biopsies may be done as a source of germline DNA.",[9],[60],"Biopsy",[62],{"name":63,"affiliation":5,"role":64},"Kim E. Nichols, MD","PRINCIPAL_INVESTIGATOR",[66],{"name":63,"role":67,"phone":68,"phoneExt":10,"email":69},"CONTACT","888-226-4343","referralinfo@stjude.org",[71],{"facility":5,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"RECRUITING","Memphis","Tennessee","38105","United States","US",{"type":79,"coordinates":80},"Point",[81,82],-90.04898,35.14953,{"lat":82,"lon":81},[85,86],{"name":63,"role":67,"phone":68,"phoneExt":10,"email":69},{"name":63,"role":64,"phone":10,"phoneExt":10,"email":10},{"type":88,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100249818","next-generation-sequencing-of-normal-tissues-prospectively-in-pediatric-oncology-patients-100249818",false,"NCT02530658","Next Generation Sequencing of Normal Tissues Prospectively in Pediatric Oncology Patients","Genomes for Kids (G4K)","Inclusion Criteria:\n\n* St. Jude patients prospectively identified at the time of study activation with a diagnosed solid or liquid tumor (benign or malignant).\n* Adequate tissue must be available (e.g. sufficient germline and\u002For tumor tissue, from which \\>1 µg DNA and \\>0.1 µg RNA must be isolated). Patients who have no tumor tissue available may enroll using only germline sample.\n\nExclusion Criteria:\n\n* Past history of hematopoietic stem cell transplantation (or other condition that would result in hematopoietic cell DNA failing to match host tissue DNA).\n* Tumor or germline tissue not meeting the criteria listed above.\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.\n* Participants who are unable to read, write or converse fluently in English or Spanish will be excluded from Prespecified Objectives 3 and 4.","ALL",{"count":98,"type":99},2500,"ESTIMATED","OBSERVATIONAL","The development of next generation sequencing (NGS) techniques, including whole genome (WGS), exome (WES) and RNA sequencing has revolutionized the ability of investigators to query the molecular mechanisms underlying tumor formation. Through the Pediatric Cancer Genome Project (PCGP), investigators at St. Jude Children's Research Hospital (SJCRH) have successfully used NGS approaches to evaluate more than 1,000 pediatric cancers ranging from hematologic malignancies to central nervous system (CNS) and non-CNS solid tumors. From these and related studies, it has become clear that genomic approaches can accurately classify tumors into distinct pathologic and prognostic subtypes and detect alterations in cellular pathways that may serve as novel therapeutic targets. Collectively, these studies suggest that by characterizing the genomic make-up of individual tumors, investigators will be able to develop personalized and potentially more effective cancer treatments and\u002For preventive measures.\n\nThis protocol was initially enacted to usher NGS approaches into routine clinical care. During the initial phase of the G4K protocol, 310 participants were recruited and enrolled onto the study. Tumor and\u002For germline sequencing was completed on all 310 patients, with 253 somatic reports generated (representing 96% of the 263 participants for whom tumor tissue was available and analyzed) and 301 germline reports generated (100% of the 301 participants who agreed to the receipt of germline results). Analyses of the study data are ongoing with plans to prepare initial manuscripts within the next several months. Due to the successful initial execution of the G4K protocol, clinical genomic sequencing of tumor and germline samples is now offered as part of standard clinical care for pediatric oncology patients at St. Jude.\n\nThe G4K protocol has now been revised. With the revision, the study team will record, store and analyze germline and tumor genomic information. Through the collection of these data, we will examine how germline mutations in 150 cancer predisposition genes influence clinical presentation, tumor histology, tumor genomic findings, response to therapy and long-term outcomes. The overall goals of this research are to further define the prevalence, spectrum and heritability of germline variants in these genes and to decipher how germline mutations influence the phenotypes of an expanding array of cancer predisposition syndromes. These studies allow us to provide more accurate genetic counseling and management strategies to future children harboring mutations in these genes.\n\nThis remains a non-therapeutic study. Investigators anticipate a sample size of approximately 2500 patients who will be recruited over the next 7 years.",[103],"Solid, Liquid, Central Nervous System Tumors",[105,106,107,108,109,110,111,112,113,114,115],"Genetic Predisposition","Pediatric","Genomic Analysis","Heritable Disease","Cancer Risk","Genetic Counseling","DNA","Clinical Genomics","Clinical Decision-Making","Treatment Planning","Germline","2026-06-15",{"date":118,"type":119},"2026-06-17","ACTUAL",{"date":121,"type":119},"2015-08-28",{"date":123,"type":99},"2038-12-31",{"name":5,"class":6},1]