Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:38 AM
Study NCT ID:
NCT07398456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-12
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5500}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-04', 'lastUpdatePostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Baseline BBST Results', 'timeFrame': '1 year', 'description': 'Number of positive and negative BBST results at baseline testing.'}, {'measure': 'Follow-Up BBST Results', 'timeFrame': '1 year after initial result', 'description': 'Number of positive and negative BBST results at follow-up test'}, {'measure': 'BBST+ Follow-Up', 'timeFrame': '1 year', 'description': 'Number of BBST positives who received follow-up colonoscopy'}, {'measure': 'BBST+/Colonoscopy- Follow-Up', 'timeFrame': '1 year after negative colonoscopy', 'description': 'Percentage of BBST-positive/colonoscopy-negative patients who accept and complete the follow-up BBST after negative colonoscopy.'}], 'primaryOutcomes': [{'measure': 'Blood-Based Screening Test (BBST) Follow-Up', 'timeFrame': '1 year after initial result', 'description': 'Assess the number of patients with a negative BBST result who accept and complete a follow-up BBST.'}], 'secondaryOutcomes': [{'measure': 'Patient Screening Test Preference', 'timeFrame': '1 year', 'description': 'Assess patient preference rates and test completion rates for stool tests, colonoscopy, and blood-based CRC screening modalities.'}, {'measure': 'Screening Rates', 'timeFrame': '1 year', 'description': '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': 'Intervention Efficacy', 'timeFrame': '1 year', 'description': 'Assess whether use of a digital patient navigation tool +/- traditional patient navigation leads to an increased rate of completion of colonoscopy in those with a positive blood or stool test.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood-based screening test', 'cancer risk', 'colorectal cancer risk', 'circulating tumor DNA', 'cell-free DNA', 'colorectal cancer screening'], 'conditions': ['Colorectal Cancer (CRC) Screening']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '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/or 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.'}, 'identificationModule': {'nctId': 'NCT07398456', 'acronym': 'SHIELD-TX', 'briefTitle': 'Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas', 'organization': {'class': 'OTHER', 'fullName': 'Baylor Research Institute'}, 'officialTitle': 'Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas', 'orgStudyIdInfo': {'id': 'IRB TBD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'App Intervention', 'description': 'Patients on the app intervention arm will receive educational messages via their healthcare portal smartphone app.', 'interventionNames': ['Other: Educational Information via Smartphone App']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Support', 'description': 'Patients on the standard support arm who receive a positive blood test result and either do not access their healthcare portal smartphone app and/or 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.'}], 'interventions': [{'name': 'Educational Information via Smartphone App', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['App Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Page E Blas, MA', 'role': 'CONTACT', 'email': 'page.blas@bswhealth.org', 'phone': '214-820-5424'}, {'name': 'Ronan Kelly, MD MBA FASCO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baylor University Medical Center, Baylor Charles A Sammons Cancer Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Page E Blas, MA', 'role': 'CONTACT', 'email': 'page.blas@bswhealth.org', 'phone': '214-820-5424'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}