Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-28 @ 7:03 PM
Study NCT ID:
NCT05692466
Status:
UNKNOWN
Last Update Posted:
2023-03-03
First Post:
2021-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Discovering Novel Cancer Treatment Options Using a Comprehensive NGS-based Molecular Testing Panel in the Community Setting ("DINOSAur")
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 572}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2021-12-21', 'studyFirstSubmitQcDate': '2023-01-10', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'European Organization for Research and Treatment of Cancer quality of life Questionnaire-C30 (QLQ-C30)', 'timeFrame': '2 years', 'description': 'The EORTC Core Questionnaire (QLQ-C30) includes six clearly distinguishable functioning scales that have been thoroughly tested and validated on an international level and that are available in 110 different language versions.'}], 'secondaryOutcomes': [{'measure': 'Compare the proportion of patients enrolling in clinical trials', 'timeFrame': '2 years', 'description': 'To compare the proportion of enrolling in clinical trials between cancers patients who received the CMT versus cancer patients with no CMT.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stage III Solid Tumors', 'Stage IV Solid Tumors']}, 'descriptionModule': {'briefSummary': 'To prospectively identify cancer patients whose tumors express specific molecular markers targeted by therapeutic agents from a comprehensive molecular test, for the purpose of selecting the most clinically appropriate treatment in a pragmatic two arm trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed cancer patients at the pathology level.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have given informed consent in accordance with the methods and procedures of this study\n* Diagnosis of cancer (stage 3 and stage 4; solid tumors only) requiring medical care\n* Patients who have not received treatment related to his/her cancer\n* Patients who are willing to sign a release of medical records to the research team\n* Male and female patients ≥18 years of age\n* Patients under oncology care of a participating site\n* Sufficient clinical status for collection of biospecimen samples within usual care\n* Patients who have insurance coverage for CMT\n\nExclusion Criteria:\n\n* Patients considered minors in the jurisdiction where the protocol is conducted.\n* Patients who are prisoners and pregnant women.\n* Patients who cannot provide consent and did not sign a power of attorney.'}, 'identificationModule': {'nctId': 'NCT05692466', 'acronym': 'DINOSAur', 'briefTitle': 'Discovering Novel Cancer Treatment Options Using a Comprehensive NGS-based Molecular Testing Panel in the Community Setting ("DINOSAur")', 'organization': {'class': 'OTHER', 'fullName': 'Glendale Adventist Medical Center d/b/a Adventist Health Glendale'}, 'officialTitle': 'Discovering Novel Cancer Treatment Options Using a Comprehensive NGS-based Molecular Testing Panel in the Community Setting ("DINOSAur")', 'orgStudyIdInfo': {'id': 'DINOSAur'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Active', 'description': 'Newly diagnosed cancer patients.', 'interventionNames': ['Diagnostic Test: Comprehensive molecular panel test', 'Other: EORTC QLQ-30']}, {'label': 'Control', 'description': 'Historically diagnosed cancer patients.'}], 'interventions': [{'name': 'Comprehensive molecular panel test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Lab test', 'armGroupLabels': ['Active']}, {'name': 'EORTC QLQ-30', 'type': 'OTHER', 'description': 'Quality of life questionnaire', 'armGroupLabels': ['Active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mihran Shirinian, M.D.', 'role': 'CONTACT', 'email': 'mshirin@aol.com', 'phone': '818-543-7574'}, {'name': 'Mihran Shirinian, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Adventist Health Glendale', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}], 'centralContacts': [{'name': 'Mihran H Shirinian, MD', 'role': 'CONTACT', 'email': 'mshirin@aol.com', 'phone': '818-543-7574'}, {'name': 'Lily Villalobos, MHA', 'role': 'CONTACT', 'email': 'villall3@ah.org', 'phone': '818-409-8009'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glendale Adventist Medical Center d/b/a Adventist Health Glendale', 'class': 'OTHER'}, 'collaborators': [{'name': 'Caris Life Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mihran Shirinian', 'investigatorAffiliation': 'Glendale Adventist Medical Center d/b/a Adventist Health Glendale'}}}}