[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571929":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":28,"locations":34,"responsibleParty":175,"collaborators":177,"id":188,"slug":189,"hasResults":190,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":190,"sex":196,"minAge":10,"maxAge":197,"enrollmentInfo":198,"targetDuration":10,"studyType":201,"phases":10,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":118,"whyStopped":10,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Test cohort",null,"All participants in the experimental cohort will provide blood samples tri-annually (every 4 months) for 4 years, either at the study hospital or at a local blood laboratory (e.g., LifeLabs). Whenever possible, patients will have research blood collected at the same time as routine blood collections for clinical purposes to avoid additional venipunctures. The samples will undergo cfDNA analysis and all results will be returned to participants by the study team. Participants who receive a \"positive\" cfDNA assay result will be offered follow-up diagnostic procedures to confirm or rule out the presence of a malignancy. Participants will also complete questionnaires and semi-structured interviews to explore their experience with cfDNA testing and understand perceptions of the clinical utility of cfDNA tests for HCS management.",[13],"Diagnostic Test: Cell-free DNA analysis",{"label":15,"type":10,"description":16,"interventionNames":10},"Control","Participants in the control cohort will not receive the cfDNA blood test and will continue to receive standard-of-care cancer surveillance according to current guidelines, as they were prior to study enrollment. Participants will complete questionnaires and semi-structured interviews to explore their experience with cfDNA testing and to understand their perception of the clinical utility of cfDNA tests for HCS management.",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DIAGNOSTIC_TEST","Cell-free DNA analysis","Analysis of cell-free DNA in blood plasma will involve targeted sequencing of key cancer-related genes, cell-free methylated DNA immunoprecipitation and high-throughput sequencing (cfMeDIP-seq), and shallow whole genome sequencing (sWGS).",[9],[24],{"name":25,"affiliation":26,"role":27},"Raymond Kim, MD","Princess Margaret Cancer Centre","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Julia Sobotka, MSc","CONTACT","416-409-1387","charm@uhn.ca",[35,59,79,95,116,129,140,154],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"BC Cancer Agency","NOT_YET_RECRUITING","Vancouver","British Columbia","V5Z 4E6","Canada","CA",{"type":44,"coordinates":45},"Point",[46,47],-123.11934,49.24966,{"lat":47,"lon":46},[50,55,58],{"name":51,"role":31,"phone":52,"phoneExt":53,"email":54},"Intan Schrader, MD","604-877-6000","Ext. 672198","ischrader@bccancer.bc.ca",{"name":56,"role":31,"phone":10,"phoneExt":10,"email":57},"Sara Singh","sara.singh@bccancer.bc.ca",{"name":51,"role":27,"phone":10,"phoneExt":10,"email":10},{"facility":60,"status":37,"city":61,"state":62,"zip":63,"country":41,"countryCode":42,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Eastern Health","St. John's","Newfoundland and Labrador","A1B 3V6",{"type":44,"coordinates":65},[66,67],-52.70931,47.56494,{"lat":67,"lon":66},[70,74,77],{"name":71,"role":31,"phone":72,"phoneExt":10,"email":73},"Lesa Dawson","709-749-9686","lmdawson@mun.ca",{"name":75,"role":31,"phone":10,"phoneExt":10,"email":76},"Stacy Whittle","stacy.whittle@easternhealth.ca",{"name":78,"role":27,"phone":10,"phoneExt":10,"email":10},"Lesa Dawson, MD",{"facility":80,"status":37,"city":81,"state":82,"zip":83,"country":41,"countryCode":42,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"IWK Health Centre","Halifax","Nova Scotia","B3K 6R8",{"type":44,"coordinates":85},[86,87],-63.57688,44.64269,{"lat":87,"lon":86},[90,94],{"name":91,"role":31,"phone":92,"phoneExt":10,"email":93},"Lynette Penney, MD","902-470-8754","lynette.penney@iwk.nshealth.ca",{"name":91,"role":27,"phone":10,"phoneExt":10,"email":10},{"facility":96,"status":37,"city":97,"state":98,"zip":99,"country":41,"countryCode":42,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"The Hospital for Sick Children","Toronto","Ontario","M5G 1E8",{"type":44,"coordinates":101},[102,103],-79.39864,43.70643,{"lat":103,"lon":102},[106,110,115],{"name":107,"role":31,"phone":108,"phoneExt":10,"email":109},"Ann Gong","416-813-8204","ann.gong@sickkids.ca",{"name":111,"role":31,"phone":112,"phoneExt":113,"email":114},"David Malkin, MD","416-813-5348","Ex 305348","david.malkin@sickkids.ca",{"name":111,"role":27,"phone":10,"phoneExt":10,"email":10},{"facility":117,"status":118,"city":97,"state":98,"zip":119,"country":41,"countryCode":42,"cosmosGeoPoint":120,"geoPoint":122,"contacts":123},"Sinai Health System","RECRUITING","M5G 1X5",{"type":44,"coordinates":121},[102,103],{"lat":103,"lon":102},[124,128],{"name":25,"role":31,"phone":125,"phoneExt":126,"email":127},"416-586-4800","Ext. 4220","raymond.kim@uhn.ca",{"name":25,"role":27,"phone":10,"phoneExt":10,"email":10},{"facility":130,"status":118,"city":97,"state":98,"zip":131,"country":41,"countryCode":42,"cosmosGeoPoint":132,"geoPoint":134,"contacts":135},"University Health Network","M5G 2M9",{"type":44,"coordinates":133},[102,103],{"lat":103,"lon":102},[136,137,139],{"name":25,"role":31,"phone":125,"phoneExt":126,"email":127},{"name":30,"role":31,"phone":10,"phoneExt":32,"email":138},"julia.sobotka@uhn.ca",{"name":25,"role":27,"phone":10,"phoneExt":10,"email":10},{"facility":141,"status":37,"city":97,"state":98,"zip":142,"country":41,"countryCode":42,"cosmosGeoPoint":143,"geoPoint":145,"contacts":146},"Women's College Hospital","M5S 1B2",{"type":44,"coordinates":144},[102,103],{"lat":103,"lon":102},[147,152],{"name":148,"role":31,"phone":149,"phoneExt":150,"email":151},"Gabby Ene","(416)-946-4501","Ext. 3969","gabrielle.ene@uhnresearch.ca",{"name":153,"role":27,"phone":10,"phoneExt":10,"email":10},"Michelle Jacobson, MD",{"facility":155,"status":37,"city":156,"state":157,"zip":158,"country":41,"countryCode":42,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Jewish General Hospital","Montreal","Quebec","H3T 1E2",{"type":44,"coordinates":160},[161,162],-73.58781,45.50884,{"lat":162,"lon":161},[165,170,173,174],{"name":166,"role":31,"phone":167,"phoneExt":168,"email":169},"William Foulkes, MD","514-934-1934","Ext 44121","william.foulkes@mcgill.ca",{"name":171,"role":31,"phone":10,"phoneExt":10,"email":172},"Mark Basik, MD","mark.basik@mcgill.ca",{"name":166,"role":27,"phone":10,"phoneExt":10,"email":10},{"name":171,"role":27,"phone":10,"phoneExt":10,"email":10},{"type":176,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[178,180,181,182,183,184,185,187],{"name":179,"class":6},"British Columbia Cancer Agency",{"name":60,"class":6},{"name":80,"class":6},{"name":155,"class":6},{"name":117,"class":6},{"name":96,"class":6},{"name":186,"class":6},"University of Alberta",{"name":141,"class":6},"100571929","cfdna-in-hereditary-and-high-risk-malignancies-2-100571929",false,"NCT06726642","CfDNA in Hereditary And High-risk Malignancies 2","CfDNA in Hereditary And High-risk Malignancies (CHARM) 2: Evaluating the Performance of a cfDNA Blood Test for Early Cancer Detection","CHARM2","Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of hereditary breast and ovarian cancer (HBOC), Lynch Syndrome (LS), Neurofibromatosis type I (NF1), Li-Fraumeni Syndrome (LFS), PALB2, and Hereditary Diffuse Gastric Cancer (HDGC), (i.e., patients with an identified pathogenic variant in the respective cancer predisposition gene, or patients with uninformative genetic testing but with a family history suggestive of the cancer predisposition syndrome).\n* Patients must be receiving standard-of-care clinical assessment for cancer by a managing physician under a provincial screening program or cancer surveillance protocol.\n* All patients must have signed and dated an informed consent form for this study.\n\nExclusion Criteria:\n\n* Patients must not have a personal history of cancer diagnosed and treated within 3 years prior to the expected first sample collection date for this study. If a patient has a personal history of cancer, treatment must have been completed successfully at least 3 years prior to first study sample collection.\n* Patients diagnosed more than 3 years prior to the expected first sample collection date, but never been treated for the cancer.\n* Patients undergoing investigations for a clinical suspicion of cancer.\n* Patients who are not able to comply with the protocol (i.e., tri-annual blood sample collection if randomized into the experimental cohort).","ALL","90 Years",{"count":199,"type":200},1000,"ESTIMATED","OBSERVATIONAL","The goal of this study is to understand the performance of an experimental blood test that aims to detect early tumors in patients with hereditary cancer syndromes. If this new blood test is accurate, it could be used to screen patients for cancer and allow for earlier cancer detection. The study will compare cancer detection rates between those receiving the new blood test and those receiving standard care, assess if the test leads to earlier cancer diagnosis, and evaluate its impact on patient outcomes. The study will also use questionnaires and interviews to understand how patients feel about the blood test, its incorporation into routine medical care, and perceptions of the medical value of test results. This research could lead to more effective and less invasive cancer screening for high-risk individuals.",[204],"Hereditary Cancer Syndrome",[206,207,208,209,210,211,212,213,214,215,216],"cfDNA","cell-free DNA","Hereditary cancer syndrome","BRCA1","BRCA2","Lynch Syndrome","Hereditary breast and ovarian cancer (HBOC)","Liquid biopsy","Circulating tumor DNA","Hereditary Diffuse Gastric Cancer (HDGC)","Li-Fraumeni syndrome","2025-12-08",{"date":219,"type":220},"2025-12-16","ACTUAL",{"date":222,"type":220},"2024-04-19",{"date":224,"type":200},"2031-12",{"name":5,"class":6},8]