Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-31 @ 10:31 AM
Study NCT ID:
NCT07046260
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study to Assess a Diagnostic Aid for Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1650}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-05-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-06-09', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance of a diagnostic aid test among individuals presenting with symptoms, signs, and/or clinical findings suggestive of one or more cancers originating from the protocol-specified sites.', 'timeFrame': '18 months', 'description': '* Proportion of positive test results among all confirmed cancer cases.\n* Proportion of negative test results among all subjects without a confirmed cancer diagnosis.\n* Proportion of subjects without a confirmed cancer diagnosis among all those who test negative.'}], 'secondaryOutcomes': [{'measure': 'Intrinsic accuracy of the test separately within cancer types and stages.', 'timeFrame': '18 months', 'description': '* Sensitivity for early-stage (I and II) and late-stage (III and IV) cancer cases.\n* Sensitivity per cancer indication.'}, {'measure': 'Effect of demographic covariates on the diagnostic performance of the test.', 'timeFrame': '18 months', 'description': 'Performance metrics within clinically relevant subgroups defined by demographic factors.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Diagnostic', 'Oncology', 'Test', 'Observational'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the performance of a blood-based diagnostic aid test for cancer detection in individuals presenting with symptoms, signs, or findings that raise clinical suspicion for cancer.', 'detailedDescription': 'Subjects 45 years of age and older presenting with symptoms, signs, and/or findings suggestive of one or more cancers originating from protocol-specified sites will be enrolled. Subjects will complete a blood draw for analysis by the investigational diagnostic aid test. For subjects with suspected cancer at enrollment, clinical outcomes will be determined following completion of a standard-of-care diagnostic work-up as clinically indicated. Subjects with a confirmed cancer diagnosis at enrollment must be treatment-naïve and will have diagnosis details collected at the time of enrollment. The results of the investigational diagnostic aid test will not be provided to investigators, treating clinicians, or subjects. Personnel performing clinical evaluations, determining final diagnoses, or reviewing diagnostic imaging and pathology reports will remain blinded to the results of the investigational test. All testing and associated analyses will be conducted in a blinded fashion, and test results will not inform clinical decision-making.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will enroll individuals 45 years of age or older who present with symptoms, signs, and/or have findings leading to a clinical suspicion or a diagnosis of one or more cancers originating from the following sites:\n\n* Biliary Tract\n* Colon\n* Esophagogastric Junction (EGJ)\n* Esophagus\n* Gallbladder\n* Head and Neck\n* Liver\n* Lung\n* Lymphatic System\n* Ovary\n* Pancreas\n* Rectum\n* Stomach', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects aged ≥45 years at the time of informed consent\n2. Provided written or electronic informed consent, according to local guidelines, signed and dated by the Subject or by a legal guardian prior to the performance of any study- specific procedures, sampling, or analyses\n3. Presentation with symptoms, signs, and/or findings that raise clinical suspicion of one or more of the protocol-specified sites AND\n\n 1. undergoing diagnostic work-up to determine if cancer is present, but do not yet have a confirmed cancer diagnosis. Subject must be willing to undergo a standard diagnostic work-up per local SoC to establish clinical truth regarding the presence or absence of cancer OR\n 2. have a confirmed diagnosis of cancer, determined within 45 days prior to signing the Informed Consent Form, based on standard diagnostic procedures (histopathology, imaging, etc.) following presentation with symptoms, signs, and/or findings that raised a clinical suspicion of one or more cancers originating from the protocol-specified sites. Must be treatment-naïve for the diagnosed cancer at the time of enrollment.\n\nExclusion Criteria:\n\n1. History of any prior invasive or hematological malignancy (Individuals with completely resected ductal carcinoma in-situ or non-melanoma skin cancer are permitted)\n2. Subject is suffering from any febrile illness defined as a temperature \\>101.5°F within the last 48 hours\n3. Subject is pregnant (Self-reported)\n4. Subject is a recipient of an organ transplant, blood transfusion within 120 days, or prior non-autologous (allogeneic) bone marrow or stem cell transplant (Subject with a corneal transplant can be considered for study entry)\n5. Inability or unwillingness to comply with study procedures or follow-up requirement\n6. Previous or current participation in any study sponsored by, or employment with, Harbinger Health\n7. Participation in a clinical research study sponsored by an external organization which may interfere with study procedures or outcomes\n8. Subject has any condition that in the opinion of the Investigator should preclude participation in the study'}, 'identificationModule': {'nctId': 'NCT07046260', 'acronym': 'PROCARES', 'briefTitle': 'Prospective Study to Assess a Diagnostic Aid for Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Harbinger Health'}, 'officialTitle': 'Prospective Cohort Study With Case Enrichment to Assess a Diagnostic Aid for Cancer in Symptomatic Subjects (PROCARES)', 'orgStudyIdInfo': {'id': 'HH-PRT-0005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with clinical suspicion of cancer or patients recently diagnosed with Cancer', 'description': 'People who have signs, symptoms, and/or findings that their doctor suspects may be related to cancer, or who have recently been diagnosed with cancer and have not received treatment for this cancer.', 'interventionNames': ['Other: Blood sample collection']}], 'interventions': [{'name': 'Blood sample collection', 'type': 'OTHER', 'otherNames': ['Diagnostic Aid Test'], 'description': 'The study will collect up to 40 mL of whole peripheral blood in Streck Cell-Free DNA BCT® tubes from each Subject.', 'armGroupLabels': ['Patients with clinical suspicion of cancer or patients recently diagnosed with Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92064', 'city': 'Poway', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gladiz Ponce', 'role': 'CONTACT', 'email': 'gponce@jointopo.com', 'phone': '(858) 260-3286'}], 'facility': 'Palomar Health', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ian Reagin', 'role': 'CONTACT', 'email': 'ireagin@jointopo.com', 'phone': '303-228-8616'}], 'facility': 'Rocky Mountain Gastroenterology', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'zip': '33073', 'city': 'Coconut Creek', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Danielle Fritz', 'role': 'CONTACT', 'email': 'dfritz@femwell.com', 'phone': '954-420-9182'}], 'facility': 'Zoyla Almeida, MD PA', 'geoPoint': {'lat': 26.25175, 'lon': -80.17894}}, {'zip': '33477', 'city': 'Jupiter', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Natasha Rodriguez', 'role': 'CONTACT', 'email': 'nrodriguez@yanuvia.com', 'phone': '561-979-2001'}], 'facility': 'Azzi ENT and Facial Reconstructive Surgery', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rafael Gonzalez', 'role': 'CONTACT', 'email': 'rgonzalez@millenniummedresearch.com', 'phone': '210-363-5481'}], 'facility': 'Millennium Medical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Douglas Winter', 'role': 'CONTACT', 'email': 'dwinter@gastro-md.com', 'phone': '386-668-2221', 'phoneExt': '1049'}], 'facility': 'Gastroenterology of Greater Orlando', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chantal Pelzer', 'role': 'CONTACT', 'email': 'start-up@innovoresearch.com', 'phone': '336-972-2909'}], 'facility': 'Millennium Physician Group', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '34994', 'city': 'Stuart', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katrina Petters', 'role': 'CONTACT', 'email': 'katrina@stuartoncology.com', 'phone': '772-276-7242'}], 'facility': 'Stuart Oncology Associates', 'geoPoint': {'lat': 27.19755, 'lon': -80.25283}}, {'zip': '30680', 'city': 'Winder', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daphne Delee', 'role': 'CONTACT', 'email': 'ddelee@pulmonarysleepmed.com', 'phone': '770-586-0300'}], 'facility': 'Pulmonary & Sleep Specialists of Northeast Georgia, P.C', 'geoPoint': {'lat': 33.99261, 'lon': -83.72017}}, {'zip': '61820', 'city': 'Champaign', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan Rodgers', 'role': 'CONTACT', 'email': 'mrodgers@christieclinic.com', 'phone': '217-366-8056'}], 'facility': 'Christie Clinic', 'geoPoint': {'lat': 40.11642, 'lon': -88.24338}}, {'zip': '60521', 'city': 'Hinsdale', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ava Baftirovska', 'role': 'CONTACT', 'email': 'abaftirovska@hopenheal.care', 'phone': '630-456-2907', 'phoneExt': '107'}], 'facility': 'Hope and Healing Cancer Services', 'geoPoint': {'lat': 41.80086, 'lon': -87.93701}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chantal Pelzer', 'role': 'CONTACT', 'email': 'cpelzer@innovoresearch.com', 'phone': '336-972-2909'}], 'facility': 'Iowa Clinic', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '67502', 'city': 'Hutchinson', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Martens', 'role': 'CONTACT', 'email': 'amartens@innovoresearch.com', 'phone': '620-694-2066'}], 'facility': 'Hutchinson Clinic', 'geoPoint': {'lat': 38.06084, 'lon': -97.92977}}, {'zip': '70403', 'city': 'Hammond', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tiffany Ross', 'role': 'CONTACT', 'email': 'Tiffany@northlakegastro.com', 'phone': '985-542-1334'}], 'facility': 'Northlake Gastroenterology Associates', 'geoPoint': {'lat': 30.50463, 'lon': -90.46293}}, {'zip': '48197', 'city': 'Ypsilanti', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Talia Hight', 'role': 'CONTACT', 'email': 'talia@jointopo.com', 'phone': '714-793-3100'}], 'facility': 'Huron Gastroenterology', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}, {'zip': '07046', 'city': 'Mountain Lakes', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erika Ramirez', 'role': 'CONTACT', 'email': 'eramirez@ohsnj.com', 'phone': '973-316-1701'}], 'facility': 'Oncology Hematology Specialists', 'geoPoint': {'lat': 40.89482, 'lon': -74.43293}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Talia Hight', 'role': 'CONTACT', 'email': 'talia@jointopo.com', 'phone': '714-793-3100'}], 'facility': 'Southwest Gastroenterology', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10512', 'city': 'Carmel', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Delacruz', 'role': 'CONTACT', 'email': 'sdelacruz@putnamgi.com', 'phone': '845-278-5223'}], 'facility': 'Westchester Putnam Gastro', 'geoPoint': {'lat': 41.43009, 'lon': -73.68013}}, {'zip': '13066', 'city': 'Fayetteville', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tabatha Jackson', 'role': 'CONTACT', 'email': 'tjackson@assocgastro.com', 'phone': '315-329-7300'}], 'facility': 'Associated Gastroenterologists of Central New York', 'geoPoint': {'lat': 43.02979, 'lon': -76.00436}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jarrod Vaughn', 'role': 'CONTACT', 'email': 'JaVaughn@wilmingtonhealth.com', 'phone': '910-362-4040'}], 'facility': 'Wilmington Health, PLLC', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '73102', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jamie Massengill', 'role': 'CONTACT', 'email': 'feas@clinitiative.com', 'phone': '210-363-5481'}], 'facility': 'Hightower Clinical', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '17110', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Balay', 'role': 'CONTACT', 'email': 'jbalay@gicare.com', 'phone': '717-914-7770'}], 'facility': 'Susquehanna Research Group', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '19610', 'city': 'Wyomissing', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lisa Hill', 'role': 'CONTACT', 'email': 'lhill@lungmd.net', 'phone': '610-685-5864'}], 'facility': 'Respiratory Specialists', 'geoPoint': {'lat': 40.32954, 'lon': -75.96521}}, {'zip': '37909', 'city': 'Knoxville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kaitlynn Smith', 'role': 'CONTACT', 'email': 'ksmith@gihealthcare.com', 'phone': '865-588-5121'}], 'facility': 'GIA Clinical Trials, LLC', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '78735', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christy Springs', 'role': 'CONTACT', 'email': 'csprings@innovoresearch.com', 'phone': '512-892-7076'}], 'facility': 'Premier Family Physicians', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77340', 'city': 'Huntsville', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicole Sehgal', 'role': 'CONTACT', 'email': 'nicolesehgal@yahoo.com', 'phone': '936-439-4835'}], 'facility': 'Huntsville Research Institute, LLC', 'geoPoint': {'lat': 30.72353, 'lon': -95.55078}}, {'zip': '77339', 'city': 'Kingwood', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katie Thomas', 'role': 'CONTACT', 'email': 'kthomas@activian.com', 'phone': '832-225-4800'}], 'facility': 'Activian Clinical Research', 'geoPoint': {'lat': 30.05691, 'lon': -95.18349}}], 'centralContacts': [{'name': 'Sara Bardwell', 'role': 'CONTACT', 'email': 'sbardwell@harbinger-health.com', 'phone': '(617) 446-9266'}, {'name': 'Nate Ruffle-Deignan', 'role': 'CONTACT', 'email': 'nrdeignan@harbinger-health.com'}], 'overallOfficials': [{'name': 'Luke Pike, MD, DPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harbinger Health', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}