[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623578":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":43,"studyPopulation":43,"armGroups":46,"interventions":57,"overallOfficials":43,"centralContacts":62,"locations":68,"responsibleParty":87,"collaborators":43,"id":89,"slug":43,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":43,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":115,"whyStopped":43,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Baylor Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Blood-Based Screening Test (BBST) Follow-Up","Assess the number of patients with a negative BBST result who accept and complete a follow-up BBST.","1 year after initial result",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Patient Screening Test Preference","Assess patient preference rates and test completion rates for stool tests, colonoscopy, and blood-based CRC screening modalities.","1 year",{"measure":19,"description":20,"timeFrame":17},"Screening Rates","Compare the overall screening rates in the study population to a historical cohort in which blood-based testing was not offered as an option.",{"measure":22,"description":23,"timeFrame":17},"Intervention Efficacy","Assess whether use of a digital patient navigation tool +\u002F- traditional patient navigation leads to an increased rate of completion of colonoscopy in those with a positive blood or stool test.",[25,28,31,34],{"measure":26,"description":27,"timeFrame":17},"Baseline BBST Results","Number of positive and negative BBST results at baseline testing.",{"measure":29,"description":30,"timeFrame":12},"Follow-Up BBST Results","Number of positive and negative BBST results at follow-up test",{"measure":32,"description":33,"timeFrame":17},"BBST+ Follow-Up","Number of BBST positives who received follow-up colonoscopy",{"measure":35,"description":36,"timeFrame":37},"BBST+\u002FColonoscopy- Follow-Up","Percentage of BBST-positive\u002Fcolonoscopy-negative patients who accept and complete the follow-up BBST after negative colonoscopy.","1 year after negative colonoscopy",{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":43,"timePerspective":43,"maskingInfo":44},"RANDOMIZED","PARALLEL","Patients testing positive via BBST will be randomized based on clinic location such that half of the patients receive the intervention and the other half do not.","SCREENING",null,{"masking":45,"maskingDescription":43,"whoMasked":43},"NONE",[47,53],{"label":48,"type":49,"description":50,"interventionNames":51},"App Intervention","EXPERIMENTAL","Patients on the app intervention arm will receive educational messages via their healthcare portal smartphone app.",[52],"Other: Educational Information via Smartphone App",{"label":54,"type":55,"description":56,"interventionNames":43},"Standard Support","NO_INTERVENTION","Patients on the standard support arm who receive a positive blood test result and either do not access their healthcare portal smartphone app and\u002For do not schedule a colonoscopy within 2 weeks of the blood test result will receive the standard patient navigation support offered which typically includes explanation and education regarding their positive test result and referral to a gastroenterologist or other proceduralist for a colonoscopy.",[58],{"type":6,"name":59,"description":60,"armGroupLabels":61,"otherNames":43},"Educational Information via Smartphone App","The educational messages will include information about the meaning of a positive test result, the patient's chances of having a CRC detected on colonoscopy, and the importance of early CRC detection.",[48],[63],{"name":64,"role":65,"phone":66,"phoneExt":43,"email":67},"Page E Blas, MA","CONTACT","214-820-5424","page.blas@bswhealth.org",[69],{"facility":70,"status":43,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Baylor University Medical Center, Baylor Charles A Sammons Cancer Center","Dallas","Texas","75246","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-96.80667,32.78306,{"lat":80,"lon":79},[83,84],{"name":64,"role":65,"phone":66,"phoneExt":43,"email":67},{"name":85,"role":86,"phone":43,"phoneExt":43,"email":43},"Ronan Kelly, MD MBA FASCO","PRINCIPAL_INVESTIGATOR",{"type":88,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100623578",false,"NCT07398456","Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas","SHIELD-TX","Inclusion Criteria:\n\n* patients aged 45-84 years of age\n* Considered by health-care providers to be \"average risk\" for CRC as determined by USPSTF guidelines\n* If a patient opts for BBST, they are able and willing to provide blood samples per protocol\n* Ability to understand and the willingness to participate in the study\n* Must have been seen in HTPN clinic within the past 24 months from study activation\n* Must have active MyBSW app portal account and\u002For establish account during study recruitment\n\nExclusion Criteria:\n\n* Patients with a personal history of CRC\n* Patients with a known high-risk family history of CRC precluding the patient from being average risk\n* Patients with known diagnosis of inflammatory bowel disease or history of polyps\n* Patients who are currently symptomatic for CRC such as: blood in the stool\n* Patients with any known medical condition which, in the opinion of the investigator, should preclude enrollment into the study\n* Have a recorded up to date CRC screening in the EMR (within 1 year for FIT, 3 years for mt-sDNA, 10 years for colonoscopy)\n* Patients with a previous abnormal colonoscopy finding who are due for surveillance.",true,"ALL","45 Years","84 Years",{"count":100,"type":101},5500,"ESTIMATED","INTERVENTIONAL",[104],"NA","The goal of this prospective implementation study is to understand the impact of a blood-based screening test (BBST) for colorectal cancer (CRC) on patient acceptability of and adherence to CRC screening as well as the rate of follow-up BBST in those with negative BBST at a 1-year interval.\n\nAdditional aims include assessing the impact of digital patient navigation intervention on the rate of follow-up colonoscopy in individuals with positive BBST. Patients will be randomized into the non-intervention arm or the intervention with an app arm.",[107],"Colorectal Cancer (CRC) Screening",[109,110,111,112,113,114],"blood-based screening test","cancer risk","colorectal cancer risk","circulating tumor DNA","cell-free DNA","colorectal cancer screening","NOT_YET_RECRUITING","2026-02-10",{"date":118,"type":119},"2026-02-12","ACTUAL",{"date":121,"type":101},"2026-06",{"date":123,"type":101},"2028-06",{"name":5,"class":6},1]