Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-31 @ 2:03 AM
Study NCT ID:
NCT04364503
Status:
RECRUITING
Last Update Posted:
2024-10-16
First Post:
2020-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compliant Analysis of Patient Samples and Data
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Commercial remnant samples stored at multiple LabCorp affiliates.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2030-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-11', 'studyFirstSubmitDate': '2020-04-22', 'studyFirstSubmitQcDate': '2020-04-27', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remnant samples and data for research and development', 'timeFrame': 'Retrospective and Prospective collection. Samples and data may be collected for up 12 months after enrollment.', 'description': 'Remnant samples and data for research and development'}, {'measure': 'Sample and data collection from subjects of scientific interest', 'timeFrame': 'Prospective collection. Samples and data may be collected for up to 12 months after enrollment', 'description': 'Collect additional clinical data and samples if needed from subjects tested by LabCorp or an affiliate.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Related', 'Cancer', 'Infectious Disease']}, 'descriptionModule': {'briefSummary': "Patients of scientific interest who have provided a commercial sample to LabCorp or one of its' affiliates will have their de-identified remnant samples and/or data used for research and development. Other commercial patients will be followed up on after informed consent is obtained.", 'detailedDescription': 'Arm 1 - Remnant commercial samples and data that has been de-identified of personal health information in compliance with HIPAA may be used for R\\&D studies or population-based analysis by LabCorp or affiliates.\n\nArm 2 - Collection of samples and/or data from commercial test patients requiring follow-up or from subjects of scientific interest after informed consent is obtained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Arm 1 - Female or male patient samples submitted to Sequenom or LabCorp affiliate for routine clinical care testing that no longer need to be maintained for clinical purposes.\n\nArm 2 - Female or male subjects of scientific interest who have provided written informed consent/assent.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Arm 1\n* All samples and data are de-identified and HIPAA compliant\n* Arm 2\n* Subject is of scientific interest to the Sponsor or treating physician\n* Subject provides written informed consent and has a clinical sample and/or supporting clinical data collected.\n\nExclusion Criteria:\n\n* Arm 1\n* Subject is from a US state or a country where local law restricts the use of de-identified data and/or remnants of specimens for research and/or development\n* Arm 2\n* Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent"}, 'identificationModule': {'nctId': 'NCT04364503', 'briefTitle': 'Compliant Analysis of Patient Samples and Data', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sequenom, Inc.'}, 'officialTitle': 'Use of Patient Samples and Corresponding Clinical Data for Research and Development Studies And/or Population-based Analysis', 'orgStudyIdInfo': {'id': 'SCMM-RND-402'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Multiple interventions depending on diagnostic test being run.', 'type': 'DEVICE', 'description': 'Remnant samples and corresponding data from multiple diagnostic tests will be stored for future research and development.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92121', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Graham P McLennan, MS', 'role': 'CONTACT', 'email': 'mclenng@labcorp.com', 'phone': '(858) 202-2000'}], 'facility': 'Sequenom, Inc', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'centralContacts': [{'name': 'Graham P Senior Director', 'role': 'CONTACT', 'email': 'mclenng@labcorp.com', 'phone': '(858) 202-2000'}], 'overallOfficials': [{'name': 'Graham P McLennan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sequenom, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sequenom, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Laboratory Corporation of America', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}