Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
Study NCT ID:
NCT06744595
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-12
First Post:
2024-12-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalized Education and Genetic Counseling to Increase Genetic Testing in Patients With a Known Family History of Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D005817', 'term': 'Genetic Counseling'}, {'id': 'D005820', 'term': 'Genetic Testing'}, {'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demographic factors affecting likelihood of patients meeting National Comprehensive Cancer Network (NCCN) guidelines', 'timeFrame': 'Up to 75 days', 'description': 'Will determine whether demographic factors, including socioeconomic status, affect the likelihood of a patient meeting NCCN guidelines regarding genetic counseling for those with a family history of pancreatic cancer.'}], 'secondaryOutcomes': [{'measure': 'Number of patients meeting NCCN guidelines', 'timeFrame': 'Up to 75 days', 'description': 'Will determine if portal message communication can improve the number of patients who meet NCCN guidelines at Mayo Clinic in Florida and understand their experiences.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': "This clinical trial studies whether personalized education and genetic counseling increases genetic testing in patients with a known family history of pancreatic cancer. Approximately 10% of pancreatic cancer cases are genetically linked and therefore, if a gene is found that could put a patient at risk, it could guide the patient to obtain more frequent screening for pancreatic cancer and possibly detect it earlier when it is more treatable. The current National Comprehensive Cancer Network (NCCN) guidelines suggest patients with a first-degree relative (parent, sibling, child) with pancreatic cancer be referred for a genetics consultation to discuss genetic testing if the affected family member cannot be tested. Personalized education is based on the patient's family history of pancreatic cancer and offers information regarding the current NCCN guidelines. This may be an effective method to increase patients' understanding of their pancreatic cancer risk and the NCCN guidelines. Genetic counseling is provided by an expert in hereditary disorders. The patient's family and personal medical history may be discussed, and counseling may lead to genetic testing. Personalized education and genetic counseling may increase genetic testing in patients with a known family history of pancreatic cancer.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Perform Housing-Based Socioeconomic Status (HOUSES) index analysis on 500 patients with a first-degree relative diagnosed with pancreatic cancer to see if there is a correlation with the National Comprehensive Cancer Network (NCCN) criteria.\n\nII. Offer 40 patients who did not have appropriate NCCN intervention the opportunity to have a genetic consultation (to consider genetic testing).\n\nIII. Survey patients on their knowledge and experiences of genetic testing based on family history and their decision-making when offered genetic counseling and testing.\n\nOUTLINE:\n\nPatients receive a personalized message through the Mayo portal (EPIC) with education on the NCCN guidelines for genetic counseling and an offer for standard of care (SOC) genetic counseling. Patients then receive pre-genetic test counseling on study. Patients may then optionally undergo SOC genetic testing and collection of blood or saliva samples as well as receive post-genetic test counseling on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-75 years of age\n* First-degree relative with pancreatic cancer listed in the EPIC family history tool\n* Active patient at Mayo Clinic Florida (MCF) (visits within 1/1/2023-12/31/2023 to Family Medicine and/or Gastroenterology and Hepatology)\n\nExclusion Criteria:\n\n* Patients not meeting the inclusion criteria as defined above\n* Patients with an active or past history of pancreatic cancer\n* Patients who are pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT06744595', 'briefTitle': 'Personalized Education and Genetic Counseling to Increase Genetic Testing in Patients With a Known Family History of Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Evaluation of Genetic Testing for Patients With Known Family History of Pancreatic Cancer: A Pilot Study', 'orgStudyIdInfo': {'id': '24-006906'}, 'secondaryIdInfos': [{'id': 'NCI-2024-10177', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '24-006906', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Health services research (EPIC message, genetic counseling)', 'description': 'Patients receive a personalized message through EPIC with education on the NCCN guidelines for genetic counseling and an offer for SOC genetic counseling. Patients then receive pre-genetic test counseling on study. Patients may then optionally undergo SOC genetic testing and collection of blood or saliva samples as well as receive post-genetic test counseling on study.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Other: Educational Intervention', 'Other: Electronic Health Record Review', 'Other: Genetic Counseling', 'Genetic: Genetic Testing for Cancer Risk', 'Other: Survey Administration']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo collection of blood or salvia samples', 'armGroupLabels': ['Health services research (EPIC message, genetic counseling)']}, {'name': 'Educational Intervention', 'type': 'OTHER', 'otherNames': ['Education for Intervention', 'Intervention by Education', 'Intervention through Education', 'Intervention, Educational'], 'description': 'Receive personalized EPIC message', 'armGroupLabels': ['Health services research (EPIC message, genetic counseling)']}, {'name': 'Electronic Health Record Review', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Health services research (EPIC message, genetic counseling)']}, {'name': 'Genetic Counseling', 'type': 'OTHER', 'description': 'Receive pre-genetic test counseling', 'armGroupLabels': ['Health services research (EPIC message, genetic counseling)']}, {'name': 'Genetic Counseling', 'type': 'OTHER', 'description': 'Receive post-genetic test counseling', 'armGroupLabels': ['Health services research (EPIC message, genetic counseling)']}, {'name': 'Genetic Testing for Cancer Risk', 'type': 'GENETIC', 'otherNames': ['Cancer Risk Assessment with Genetic Testing and Counseling'], 'description': 'Undergo SOC genetic testing', 'armGroupLabels': ['Health services research (EPIC message, genetic counseling)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Health services research (EPIC message, genetic counseling)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224-9980', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Adrianna D. Clapp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}