Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-25 @ 2:19 PM
Study NCT ID:
NCT05435066
Status:
COMPLETED
Last Update Posted:
2025-07-29
First Post:
2022-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Validation of Harbinger Health Test for Early Cancer Detection
Sponsor:
Organization:
Raw JSON
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The objective of this study is to collect blood samples, tissue samples, and associated clinical data from participants with a variety of solid tumor and hematologic cancers and non-cancer participants for testing and the development of a screening test for early cancer detection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed cancer subjects and non-cancer subjects', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Inclusion Criteria - Both arms\n\nSubjects must meet the following criteria in order to be included in the research study:\n\n* Written or electronic informed consent\n* Subject is 20 - 79 years of age at the time of signature of the informed consent form (ICF)\n* Male or female subjects\n\nInclusion Criteria Arm 1 - Cancer Subjects Arm 1 subjects enrolled in the study must meet the following inclusion criteria.\n\n* A confirmed diagnosis or high suspicion of cancer (stage I to IV solid cancer or hematologic cancer) by imaging within 180 days prior to enrollment; not to include myelodysplastic and myeloproliferative syndromes\n* Subject's cancer diagnosis is based upon assessment of a pathological specimen or high suspicion of cancer by imaging\n* Subject's cancer is treatment-naïve\n\nInclusion Criteria Arm 2 - Non-Cancer Subjects (All Cohorts)\n\nArm 2 subjects enrolled in the study must meet the following inclusion criteria:\n\n* Subject's health permits participation and the subject is not suspected of having cancer based on provider assessment.\n* The subject was not diagnosed with cancer or received cancer treatment within the last 5 years (persons with completely resected ductal carcinoma in-situ or non-melanoma skin cancer are permitted).\n\nPart 1B Only :\n\n\\- Subject has no known current cancer and has 1 of the follow conditions:\n\no An Advanced Adenoma (AA) of the gastrointestinal tract as defined as an adenoma that is ≤10mm in size Subjects with any one of the criteria would be eligible High grade displasia or ≥10 adenoma: any size Tubulovillous adenoma, any size Tubular adenoma ≥10mm Traditional serrated adenoma ≥10mm\n\nExclusion Criteria:\n\nSubject self-reporting OR available medical records at the time of screening are acceptable for assessment of all exclusion criteria.\n\nExclusion Criteria - Both arms\n\nSubjects who meet any of the following criteria will be excluded from study entry:\n\n* Subject is suffering from any febrile illness defined as a temperature \\>101.5°F within the last 48 hrs.\n* Subject is pregnant (by self-report of pregnancy status).\n\nExclusion Criteria Arm 1 - Cancer Subjects\n\nSubjects who meet any of the following criteria will be excluded from study entry:\n\n* Subject with a prior history of cancer within 5 years will not be allowed to participate in the study\n* More than 1 active cancer diagnosis (ie. a subject presenting with recurrent breast cancer and newly diagnosed lung cancer would be excluded; subject with prior (\\>5 years ago) treated breast cancer without recurrence and presenting with newly diagnosed lung cancer would be eligible).\n* Subject is currently receiving, or has in the past received, any of the following definitive therapies to treat their current cancer:\n\n * Surgical treatment, surgical removal, or surgical management of the cancer beyond that required to establish the cancer diagnosis. Surgical or biopsy procedures that remove more tissue than required to establish the cancer diagnosis, or that were performed to manage symptoms or initiate cancer treatment prior to blood sample collection will be considered 'definitive' and are not permissible regardless of the residual tumor mass remaining in the subject.\n * Chemotherapy (local, regional, or systemic) including chemoembolization targeted therapy;\n * Immunotherapy including cancer vaccines;\n * Hormone therapy; or\n * Radiation therapy (a single dose of palliative radiation prior to study start is allowed).\n* The subject is a recipient of an organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.\n* Subject who has undergone a bowel preparation for a gastrointestinal malignancy within 3 days of an anticipated blood draw.\n\nExclusion Criteria Arm 2 - Non-cancer Subjects\n\nSubjects who meet any of the following criteria will be excluded from study entry:\n\n\\- The subject is the recipient of an organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant."}, 'identificationModule': {'nctId': 'NCT05435066', 'acronym': 'CORE-HH', 'briefTitle': 'Development and Validation of Harbinger Health Test for Early Cancer Detection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Harbinger Health'}, 'officialTitle': 'Cancer ORigin Epigenetics-Harbinger Health - Collection of Blood and Tissue Samples From Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test', 'orgStudyIdInfo': {'id': 'HH-PRT-0001'}, 'secondaryIdInfos': [{'id': 'Tissue 32', 'type': 'OTHER', 'domain': 'SCDI'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1 - cancer group', 'description': 'Arm 1 - newly diagnosed cancer subjects', 'interventionNames': ['Diagnostic Test: Harbinger Health Test']}, {'label': 'Arm 2 - non cancer group', 'description': 'Arm 2 - non-cancer subjects', 'interventionNames': ['Diagnostic Test: Harbinger Health Test']}], 'interventions': [{'name': 'Harbinger Health Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'This trial will be used to test the ability of the Harbinger Health test to detect cancer using blood-based biomarkers in a large cohort of patients with cancer and matched non-cancer controls. The non-cancer controls will be followed for up to 1 year', 'armGroupLabels': ['Arm 1 - cancer group', 'Arm 2 - non cancer group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36526', 'city': 'Daphne', 'state': 'Alabama', 'country': 'United States', 'facility': 'Southern Cancer Center', 'geoPoint': {'lat': 30.60353, 'lon': -87.9036}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Oncology and Hematology, LLC', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Womens Cancer Care', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '86314', 'city': 'Prescott Valley', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Associates HAL', 'geoPoint': {'lat': 34.61002, 'lon': -112.31572}}, {'zip': '33324', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Cancer Medical Center', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Central California ENT Medical Group', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'South Coast Gynecologic Oncology, Inc', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'South Coast Gynecologic Oncology, INC', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Sansum Clinic', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Gynecologic Oncology Associates', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80120', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Primary Health Care', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Medical Oncology Hematology Consultants, PA', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '32803', 'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Central Florida Pulmonary Group - Altamonte Springs', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '33434', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'ENT and Allergy Associates of Florida, LLC', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Plastic Surgery Specialists of Boca Raton', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33487', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'ENT and Allergy Associates of Florida, LLC', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33487', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida Center for Gynecologic Oncology', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33437', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Urology Center of South Florida', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33472', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Cancer Surgery and Digestive Health', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'ENT and Allergy Associates of Florida, LLC', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '33073', 'city': 'Coconut Creek', 'state': 'Florida', 'country': 'United States', 'facility': 'Zoyla Almedia, MD PA', 'geoPoint': {'lat': 26.25175, 'lon': -80.17894}}, {'zip': '34950', 'city': 'Ft. Pierce', 'state': 'Florida', 'country': 'United States', 'facility': 'ENT and Allergy Associates of Florida, LLC', 'geoPoint': {'lat': 27.44671, 'lon': -80.32561}}, {'zip': '34950', 'city': 'Ft. Pierce', 'state': 'Florida', 'country': 'United States', 'facility': 'Stuart Oncology Associates', 'geoPoint': {'lat': 27.44671, 'lon': -80.32561}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'I.H.S. 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W. 21st Street', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67206', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Wichita Urology Group- P.A. - 2077 N. Webb Road', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Breast Care Specialists', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67226', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas Surgery & Recovery Center', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67226', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Wichita Urology Group- 2626 Webb Road', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '70403', 'city': 'Hammond', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Northlake Gastroenterology Associates', 'geoPoint': {'lat': 30.50463, 'lon': -90.46293}}, {'zip': '70433', 'city': 'Hammond', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Northlake Gastroenterology Associates', 'geoPoint': {'lat': 30.50463, 'lon': -90.46293}}, {'zip': '21044', 'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Oncology Hematology', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Comprehensive Urology - Farmington Hills', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '48375', 'city': 'Novi', 'state': 'Michigan', 'country': 'United States', 'facility': 'Comprehensive Urology - Novi', 'geoPoint': {'lat': 42.48059, 'lon': -83.47549}}, {'zip': '48066', 'city': 'Roseville', 'state': 'Michigan', 'country': 'United States', 'facility': 'Comprehensive Urology - Roseville', 'geoPoint': {'lat': 42.49726, 'lon': -82.93714}}, {'zip': '48066', 'city': 'Roseville', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Cancer Specialists', 'geoPoint': {'lat': 42.49726, 'lon': -82.93714}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Comprehensive Urology - Royal Oak', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '48314', 'city': 'Sterling Heights', 'state': 'Michigan', 'country': 'United States', 'facility': 'Comprehensive Urology - Sterling Heights', 'geoPoint': {'lat': 42.58031, 'lon': -83.0302}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Oncology Hematology', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Somnos Clinical Research', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '89103', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Hope Cancer Care of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89511', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Cancer Care Specialists - Reno', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '07109', 'city': 'Belleville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Cancer Care', 'geoPoint': {'lat': 40.79371, 'lon': -74.15014}}, {'zip': '08724', 'city': 'Brick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Hematology Oncology Associates', 'geoPoint': {'lat': 40.05928, 'lon': -74.13708}}, {'zip': '07306', 'city': 'Jersey City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Surgical Specialists of New York - Jersey City', 'geoPoint': {'lat': 40.72816, 'lon': -74.07764}}, {'zip': '07046', 'city': 'Mountain Lakes', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Oncology Hematology Specialists', 'geoPoint': {'lat': 40.89482, 'lon': -74.43293}}, {'zip': '07652', 'city': 'Paramus', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Center of Dermatology and Skin Surgery, LLC', 'geoPoint': {'lat': 40.94454, 'lon': -74.07542}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': "Women's Cancer Care Associates LLC", 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11102', 'city': 'Astoria', 'state': 'New York', 'country': 'United States', 'facility': 'Surgical Specialists of NY - Astoria', 'geoPoint': {'lat': 40.77205, 'lon': -73.93014}}, {'zip': '11201', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'New York Gastroenterology Associates - Pierrepont', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11234', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Gardith Joseph Medical P.C. 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