Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-02 @ 1:41 PM
Study NCT ID:
NCT05380557
Status:
TERMINATED
Last Update Posted:
2022-12-07
First Post:
2022-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ARTEMIS: Study of Patients With Early Stage Pancreatic Cancer Who Have Undergone Genetic Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples including EDTA tubes for germline testing, streck tubes for other analyses, and archival tissue sample from a previous biopsy or resection'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Low site engagement and accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-05', 'studyFirstSubmitDate': '2022-04-01', 'studyFirstSubmitQcDate': '2022-05-13', 'lastUpdatePostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Germline pathogenic variants identified on Invitae's 84 gene Multi Cancer panel", 'timeFrame': 'Will be assessed at baseline only.'}, {'measure': 'Overall survival', 'timeFrame': 'Will be assessed in patient and clinician surveys distributed every 4 months for the first year post germline testing'}, {'measure': 'Overall survival', 'timeFrame': 'Will be assessed every 6 months for years 2 - 10 post germline testing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['germline genetic testing', 'oncology', 'pancreatic cancer', 'resectable pancreatic cancer', 'early stage pancreatic cancer'], 'conditions': ['Pancreatic Adenocarcinoma', 'Pancreatic Cancer', 'Resectable Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'This study includes participants with pancreatic cancer who are undergoing genetic testing at Invitae related to their diagnosis of pancreatic cancer.\n\nOur goal in this study is two-fold. First, we would like to research whether any inherited changes in genes may be associated with pancreatic cancer. Second, we would like to learn more about patient experiences with genetic testing, such as patient understanding of the testing, health-related actions taken (or planned to take) as a result of testing, communication and action of family members based on test results, and psychological impact of testing.\n\nThis research study involves allowing collection of tumor tissue (from a prior biopsy and/or surgery), a blood sample, and sending surveys to participants for their opinion on the impact of the genetic testing as well as clinicians for relevant baseline and medical history information.', 'detailedDescription': 'Patients will be contacted for patient outcomes survey completion at months: 1, 4, 8, 12, 18, 24, 30, 36, 42, 48, 54, and 60. Patients will also be contacted for survival collection every 6 months during years 3-5 post germline testing.\n\nClinicians will be contacted for relevant medical history, treatment, and survival data at the same time points.\n\nAt baseline, 3 samples types will be collected: 1. EDTA tube for germline genetic testing. 2. Streck tubes for whole genome sequencing and other analyses. 3. Tumor block from surgical resection. If block is unavailable 10 unstained slides are an acceptable substitute.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with resectable pancreatic cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has consented to germline genetic testing\n* Patient has a histologically confirmed diagnosis of pancreatic cancer\n* Patient has undergone or is planned to undergo surgical resection with curative intent\n* Patient is willing to allow collection of a tissue sample from surgical resection\n* Patient is willing to provide research blood samples (every 6 months for 2 years)\n* Patient must be at least 18 years of age\n\nExclusion Criteria:\n\n* Patient has evidence of metastatic or recurrent pancreatic cancer at time of consent\n* Patient is unable to consent.'}, 'identificationModule': {'nctId': 'NCT05380557', 'acronym': 'ARTEMIS', 'briefTitle': 'ARTEMIS: Study of Patients With Early Stage Pancreatic Cancer Who Have Undergone Genetic Testing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Invitae Corporation'}, 'officialTitle': 'ARTEMIS: A Prospective Study of Patients With Early Stage Pancreatic Cancer Who Have Undergone Genetic Testing', 'orgStudyIdInfo': {'id': 'CR-001-15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Germline Pathogenic Variant in non-BRCA/PALB2 Gene', 'description': 'Patients will receive germline testing and provide streck tube blood samples and archival tissue sample at baseline. After germline testing results have been generated and released, patients and clinicians will be contacted for survey completion at months: 1, 4, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60 and survival collection every 6 months during years 3-10 post germline testing.', 'interventionNames': ['Diagnostic Test: Germline genetic testing']}, {'label': 'Strong family history of pancreatic cancer but no identifiable germline pathogenic variant', 'description': 'Patients will receive germline testing and provide streck tube blood samples and archival tissue sample at baseline. After germline testing results have been generated and released, patients and clinicians will be contacted for survey completion at months: 1, 4, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60 and survival collection every 6 months during years 3-10 post germline testing.', 'interventionNames': ['Diagnostic Test: Germline genetic testing']}, {'label': 'Negative germline testing and absence of strong family history', 'description': 'Patients will receive germline testing and provide streck tube blood samples and archival tissue sample at baseline. After germline testing results have been generated and released, patients and clinicians will be contacted for survey completion at months: 1, 4, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60 and survival collection every 6 months during years 3-10 post germline testing.', 'interventionNames': ['Diagnostic Test: Germline genetic testing']}, {'label': 'Pathogenic Variant in BRCA1/2 or PALB2', 'description': 'Patients will be offered enrollment into the sister trial, APOLLO (NCT04858334). Patients and clinicians will be contacted for survey completion at months: 1, 4, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60 and survival collection every 6 months during years 3-5.', 'interventionNames': ['Diagnostic Test: Germline genetic testing']}], 'interventions': [{'name': 'Germline genetic testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Germline genetic testing will be provided to each patient', 'armGroupLabels': ['Germline Pathogenic Variant in non-BRCA/PALB2 Gene', 'Negative germline testing and absence of strong family history', 'Pathogenic Variant in BRCA1/2 or PALB2', 'Strong family history of pancreatic cancer but no identifiable germline pathogenic variant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94103', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Invitae SF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Invitae may share de-identified information and data generated through the study with third parties, including biopharmaceutical companies and biomedical researchers (e.g. academic), for clinical trials, drug development, and other disease-related research purposes.\n\nOnly a subset of Invitae personnel will have access to PHI. The PHI will be stored in a secure location and will only be made available to Invitae personnel involved in the Study. Any academic publication of data analysis from this Study will use de-identified information only.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Invitae Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}