[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100400516":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":36,"locations":46,"responsibleParty":108,"collaborators":110,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":129,"studyType":130,"phases":10,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Syantra Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Investigational Population",null,"Suspected Invasive Breast Cancer (any size) or DCIS (pre-invasive) are of particular interest. Women with abnormal screening mammograms (R3-5) recalled for further investigation.\n\nInclusion criteria\n\n* Women with suspected Invasive Breast Cancer (tumours of any size and\u002For DCIS).\n* Individuals with an abnormal or suspicious screening mammogram recalled for further evaluation.\n* Suspected Invasive Breast Cancer (tumours of any size and\u002For DCIS).\n* Willing to give written Informed Consent and provide whole blood samples\n* Age 30-75 years\n\nExclusion criteria\n\n* Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy)\n* Inoperable (T4 category) or inflammatory breast cancer\n* Previous history of cancer previously at any site\n* Previous history of breast cancer\n* Concomitant or other concurrent anti-cancer therapy\n* Male\n* Existing cancer diagnosis",[13],"Diagnostic Test: Syantra DX Breast Cancer",{"label":15,"type":10,"description":16,"interventionNames":17},"Borderline (Atypica and LCIS) Population","Women with borderline pathological B3 lesions (suspected atypia Ductal or Lobular and benign proliferative disease without DCIS or invasion) Inclusion criteria\n\n* Abnormal screening mammogram with suspected benign breast disease or proliferative changes\n* Willing to give Written Informed Consent and provide whole blood samples\n* Aged 30-75 years\n\nExclusion criteria\n\n* Existing cancer diagnosis\n* Male\n* Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy)\n* Previous history of any cancer\n* Previous history of breast cancer\n* Concomitant or other concurrent anti-cancer therapy",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Control Population","Healthy Controls Inclusion criteria\n\n* Normal breast examination - No cancer detected\u002Fsuspected by physical exam, diagnostic radiology or screening mammography\n* Willing to give Written Informed Consent and provide whole blood samples\n* Aged 30-75 years\n\nExclusion criteria\n\n* Cancer diagnosis\n* Male\n* Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy)\n* Previous history of any cancer\n* Concomitant or other concurrent anti-cancer therapy",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","Syantra DX Breast Cancer","Blood test for detecting the presence of breast cancer.",[15,19,9],[29,33],{"name":30,"affiliation":31,"role":32},"Nigel Bundred, MD","Manchester University NHS Foundation Trust","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":31,"role":35},"Cliona Kirwin, MD","STUDY_DIRECTOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},"Natasha Jones","CONTACT","0161 291 4045","Natasha.Jones@mft.nhs.uk",{"name":43,"role":39,"phone":44,"phoneExt":10,"email":45},"Linda Bailey","0161 291 4492","linda.bailey3@mft.nhs.uk",[47,75,85,100],{"facility":48,"status":49,"city":50,"state":51,"zip":10,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Alberta Cancer Research Biobank","RECRUITING","Calgary","Alberta","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-114.08529,51.05011,{"lat":58,"lon":57},[61,65,68,70,73],{"name":62,"role":39,"phone":63,"phoneExt":10,"email":64},"Shannon Brown","403-521-3604","Shannon.Brown@cancercarealberta.ca",{"name":66,"role":39,"phone":10,"phoneExt":10,"email":67},"Danielle Simonot","Danielle.Simonot@cancercarealberta.ca",{"name":69,"role":32,"phone":10,"phoneExt":10,"email":10},"Kristina Rinker, PhD",{"name":71,"role":72,"phone":10,"phoneExt":10,"email":10},"Bobbi-Jo Docktor, MD","SUB_INVESTIGATOR",{"name":74,"role":72,"phone":10,"phoneExt":10,"email":10},"Don Morris, MD",{"facility":76,"status":77,"city":78,"state":10,"zip":10,"country":79,"countryCode":10,"cosmosGeoPoint":80,"geoPoint":84,"contacts":10},"Severance Hospital","COMPLETED","Soeul","South Korea",{"type":55,"coordinates":81},[82,83],126.7319,36.9168,{"lat":83,"lon":82},{"facility":86,"status":49,"city":87,"state":10,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"North Manchester General Hospital","Manchester","M23 9LT","United Kingdom","UK",{"type":55,"coordinates":92},[93,94],-2.23743,53.48095,{"lat":94,"lon":93},[97,98],{"name":38,"role":39,"phone":10,"phoneExt":10,"email":41},{"name":99,"role":32,"phone":10,"phoneExt":10,"email":10},"Nigel Bundred",{"facility":101,"status":49,"city":87,"state":10,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":102,"geoPoint":104,"contacts":105},"Wythenshawe Hospital, Southmoor Road",{"type":55,"coordinates":103},[93,94],{"lat":94,"lon":93},[106,107],{"name":38,"role":39,"phone":10,"phoneExt":10,"email":41},{"name":30,"role":32,"phone":10,"phoneExt":10,"email":10},{"type":109,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[111],{"name":112,"class":113},"University of Calgary","OTHER","100400516","a-study-to-identify-breast-cancer-idbc-100400516",false,"NCT04495244","A Study to Identify Breast Cancer (IDBC)","Investigation of a Novel Blood Test to Identify Breast Cancer (IDBC)","IDBC","Inclusion criteria\n\n* Aged 30-75 years\n* Normal breast examination - No cancer detected\u002Fsuspected by physical exam, diagnostic radiology or screening mammography\n* Women with suspected Invasive Breast Cancer\n* Individuals with an abnormal or suspicious mammogram\n* Abnormal screening mammogram with suspected benign breast disease or proliferative changes\n\nExclusion criteria\n\n* Cancer diagnosis\n* Male\n* Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy)\n* Previous history of any cancer\n* Concomitant or other concurrent anti-cancer therapy\n* Inoperable or inflammatory breast cancer",true,"FEMALE","30 Years","75 Years",{"count":127,"type":128},10000,"ESTIMATED","3 Years","OBSERVATIONAL","Detecting cancer as early as possible is key to achieving positive outcomes in response to diagnosis and treatment. The current project is aimed at validating a novel blood-based breast cancer identification test (Syantra DX Breast Cancer) that has been developed by Syantra Inc. Syantra DX Breast Cancer measures gene expression signatures in whole blood, and has been retrospectively demonstrated in 780 samples. The test uses proprietary algorithms to analyse gene expression characteristics from a novel multi-biomarker panel, and then classify a sample as positive or negative for breast cancer. Based upon test performance in a retrospective environment, a prospective validation study is being proposed.\n\nThe primary objective of this study is to validate Syantra DX Breast Cancer methodology and biomarker panel using prospective samples, well categorized by diagnostic imaging scores, pathology outcomes, and subject characteristics.",[133],"Breast Cancer Female",[135],"Detection, blood test, clinical assay","2026-08-17",{"date":138,"type":139},"2026-08-19","ACTUAL",{"date":141,"type":139},"2019-01-24",{"date":143,"type":128},"2032-12-31",{"name":5,"class":6},4]