Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 5:37 AM
Study NCT ID:
NCT04067960
Status:
COMPLETED
Last Update Posted:
2024-08-14
First Post:
2019-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacogenomics Testing in the Optimal Use of Supportive Care Medications in Stage III-IV Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D005820', 'term': 'Genetic Testing'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2019-08-22', 'studyFirstSubmitQcDate': '2019-08-22', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in symptoms, quality of life (QOL), and perceptions about pharmacogenomics (PGx) testing', 'timeFrame': 'Baseline up to 3 months post consent', 'description': 'Patient survey responses will be compared across administration time points to look for changes in symptoms, QOL, and perceptions about PGx testing.'}], 'secondaryOutcomes': [{'measure': 'Provider opinions surrounding the clinical utility/relevancy of PGx testing in cancer patients', 'timeFrame': 'Up to 3 months', 'description': 'Will qualitatively assess provider opinions surrounding the clinical utility/relevancy of PGx testing in cancer patients via the provider survey. Provider survey responses will be examined to determine the range of perceptions and experiences associated with PGx testing and result reporting for patient tests. Descriptive statistics will be used to report provider survey results.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anatomic Stage III Breast Cancer AJCC v8', 'Anatomic Stage IIIA Breast Cancer AJCC v8', 'Anatomic Stage IIIB Breast Cancer AJCC v8', 'Anatomic Stage IIIC Breast Cancer AJCC v8', 'Anatomic Stage IV Breast Cancer AJCC v8', 'Biliary Tract Carcinoma', 'Clinical Stage III Cutaneous Melanoma AJCC v8', 'Clinical Stage IV Cutaneous Melanoma AJCC v8', 'Malignant Brain Neoplasm', 'Malignant Genitourinary System Neoplasm', 'Malignant Solid Neoplasm', 'Pancreatobiliary Carcinoma', 'Pathologic Stage III Cutaneous Melanoma AJCC v8', 'Pathologic Stage IIIA Cutaneous Melanoma AJCC v8', 'Pathologic Stage IIIB Cutaneous Melanoma AJCC v8', 'Pathologic Stage IIIC Cutaneous Melanoma AJCC v8', 'Pathologic Stage IV Cutaneous Melanoma AJCC v8', 'Prognostic Stage III Breast Cancer AJCC v8', 'Prognostic Stage IIIA Breast Cancer AJCC v8', 'Prognostic Stage IIIB Breast Cancer AJCC v8', 'Prognostic Stage IIIC Breast Cancer AJCC v8', 'Prognostic Stage IV Breast Cancer AJCC v8', 'Stage III Colorectal Cancer AJCC v8', 'Stage III Ovarian Cancer AJCC v8', 'Stage III Pancreatic Cancer AJCC v8', 'Stage III Prostate Cancer AJCC v8', 'Stage IIIA Colorectal Cancer AJCC v8', 'Stage IIIA Ovarian Cancer AJCC v8', 'Stage IIIA Prostate Cancer AJCC v8', 'Stage IIIB Colorectal Cancer AJCC v8', 'Stage IIIB Ovarian Cancer AJCC v8', 'Stage IIIB Prostate Cancer AJCC v8', 'Stage IIIC Colorectal Cancer AJCC v8', 'Stage IIIC Ovarian Cancer AJCC v8', 'Stage IIIC Prostate Cancer AJCC v8', 'Stage IV Colorectal Cancer AJCC v8', 'Stage IV Ovarian Cancer AJCC v8', 'Stage IV Pancreatic Cancer AJCC v8', 'Stage IV Prostate Cancer AJCC v8', 'Stage IVA Colorectal Cancer AJCC v8', 'Stage IVA Ovarian Cancer AJCC v8', 'Stage IVA Pancreatic Cancer', 'Stage IVA Prostate Cancer AJCC v8', 'Stage IVB Colorectal Cancer AJCC v8', 'Stage IVB Ovarian Cancer AJCC v8', 'Stage IVB Pancreatic Cancer', 'Stage IVB Prostate Cancer AJCC v8', 'Stage IVC Colorectal Cancer AJCC v8']}, 'descriptionModule': {'briefSummary': "This early phase I trial studies how well a genetic test called pharmacogenomics works in directing the optimal use of supportive care medications in patients with stage III-IV cancer. Pharmacogenomics is the study of how genes may affect the body's response to and interaction with some prescription medications. Genes, which are inherited from parents, carry information that determines things such as eye color and blood type. Genes can also influence how patients process and respond to medications. Depending on the genetic makeup, some medications may work faster or slower or produce more or fewer side effects. Pharmacogenomics testing may help doctors learn more about how patients break down and process specific medications based on their genes and improve the quality of life of cancer patients receiving clinical care.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Evaluate patient perceptions surrounding their quality of life (QOL) prior to pharmacogenomics (PGx) testing and 3 months post PGx testing.\n\nII. Understand the clinical utility/relevancy of PGx testing in cancer patients at Mayo Clinic Arizona from the viewpoint of their providers.\n\nOUTLINE:\n\nPatients undergo one-time collection of saliva sample for pharmacogenomics testing. Patients also complete quality of life assessment at baseline and at 3 months after pharmacogenomics testing.\n\nAfter completion of study, patients are followed for up to 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient enrolled to Mayo Clinic IRB: 18-000326\n* Patients with stage 3 or 4 breast, colorectal, prostate/genitourinary (GU), pancreato-biliary, brain, melanoma, and ovarian cancer\n* Individuals have agreed to participate and signed the study informed consent form\n\nExclusion Criteria:\n\n* Patients with cancer types other than the ones mentioned above\n* Patient with psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent\n* Previous PGx testing with results available within Mayo Clinic electronic medical record (EMR)'}, 'identificationModule': {'nctId': 'NCT04067960', 'briefTitle': 'Pharmacogenomics Testing in the Optimal Use of Supportive Care Medications in Stage III-IV Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Precision Pharmacogenomics in Cancer Patients', 'orgStudyIdInfo': {'id': '19-002006'}, 'secondaryIdInfos': [{'id': 'NCI-2019-04725', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '19-002006', 'type': 'OTHER', 'domain': 'Mayo Clinic in Arizona'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screening (pharmacogenomics testing)', 'description': 'Patients undergo one-time collection of saliva sample for pharmacogenomics testing. Patients also complete quality of life assessment at baseline and at 3 months after pharmacogenomics testing.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Other: Genetic Testing', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo collection of saliva', 'armGroupLabels': ['Screening (pharmacogenomics testing)']}, {'name': 'Genetic Testing', 'type': 'OTHER', 'otherNames': ['genetic analysis', 'Genetic Examination', 'Genetic Test'], 'description': 'Undergo pharmacogenomics testing', 'armGroupLabels': ['Screening (pharmacogenomics testing)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Screening (pharmacogenomics testing)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Screening (pharmacogenomics testing)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Jewel Samadder, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}