Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-01 @ 4:07 PM
Study NCT ID:
NCT04270604
Status:
TERMINATED
Last Update Posted:
2024-08-02
First Post:
2019-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Sample Collection for Research and Biobanking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D006816', 'term': 'Huntington Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D002819', 'term': 'Chorea'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Skin biopsy (2-3mm) and/or blood (up to 50 mL); saliva; excess/leftover biospecimens that were (or will be) collected for other purposes (e.g., medical procedure)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1279}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The study was voluntarily terminated by the PI to focus efforts on an alternative biobanking protocol.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2019-12-20', 'studyFirstSubmitQcDate': '2020-02-13', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establishment of a diverse bank of biological samples, stem cell lines, derivatives, and associated information.', 'timeFrame': 'Baseline', 'description': 'There are no primary endpoints planned for this biobank; endpoints will be specific to research projects that utilize samples/data contained in the biobank. Projects may investigate the biology, etiology, manifestations, progression, risk factors, genetic underpinnings, and treatment of diseases, conditions, and traits.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stem cell', 'observational', 'biobank', 'disease modeling', 'genetics'], 'conditions': ['Parkinson Disease', 'Diabetes Mellitus, Type 1', 'Macular Degeneration', 'ALS', 'Cancer', 'Alzheimer Disease', 'Huntington Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://nyscf.org', 'label': 'New York Stem Cell Foundation Website'}]}, 'descriptionModule': {'briefSummary': 'The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to study different conditions and diseases by using cells from the body (such as skin or blood cells). NYSCF uses these samples to make stem cells and other types of cells, conduct research on the samples, perform genetic testing, and/or store these samples for future use.\n\nThrough this research, scientists hope to identify future treatments or even cures.', 'detailedDescription': 'Researchers at NYSCF study diverse diseases, conditions, and traits by creating "pluripotent" stem cells. These stem cells can become any cell in the human body, including cells that may be difficult, invasive, or even impossible to obtain directly. For example, researchers may create pancreatic insulin-producing cells to learn more about type 1 diabetes, or brain cells to learn more about Parkinson\'s disease.\n\nAdditionally, researchers perform genetic testing to learn more about DNA, a material in most cells that contains instructions for the body\'s development and functions (such as traits like eye color and risk of certain diseases). A piece of DNA that determines the specific role of a cell is called a "gene." If the instructions in a gene are abnormal, this can lead to disease.\n\nParticipation in the study involves: (1) completion of a health questionnaire, (2) providing a skin and/or blood sample from which stem cells may be created, (3) possible collection of a saliva sample for genetic analysis, and (4) possible future follow-up to provide additional information or learn about other research studies.\n\nThis study is not a clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with a diagnosis of one or more of the listed conditions.\n\nIndividuals with a known genetic mutation, with or without a diagnosed condition.\n\nIndividuals without a genetic mutation or condition to serve as healthy controls (a comparison group for those with conditions).', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nAge\n\n* 18 years or older or\n* Minor with parent/guardian consent\n\nBiological Sample Collection\n\n* Able and willing to provide:\n\n * new samples of blood, skin, and/or saliva specifically for use in this study and/or\n * excess/leftover samples, cell lines, and/or derivatives that were (or will be) collected for reasons other than this study\n\nExclusion Criteria:\n\n* Non-English speaking\n* Wards of the state\n* For skin samples collected specifically for this study: history of keloid formation, bleeding disorder, allergy to the anesthetic, or anticoagulation use that precludes sample collection.\n* For blood samples collected specifically for this study: bleeding disorder, or other medical condition, if the subject's condition increases the risks associated with blood collection.\n* For saliva samples: inability to produce sufficient saliva or has a condition that precludes sample collection (such as severe trismus).\n* For prospective samples: refuse to adhere to NYSCF's and/or collaborating site's COVID-19 safety protocols during the COVID-19 pandemic."}, 'identificationModule': {'nctId': 'NCT04270604', 'briefTitle': 'Biological Sample Collection for Research and Biobanking', 'organization': {'class': 'OTHER', 'fullName': 'New York Stem Cell Foundation Research Institute'}, 'officialTitle': 'Biological Sample Collection for Research and Biobanking', 'orgStudyIdInfo': {'id': '10-005'}, 'secondaryIdInfos': [{'id': '20112091', 'type': 'OTHER', 'domain': 'WCG IRB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Biological sample collection', 'type': 'OTHER', 'description': 'Biological sample collection for biobanking and research'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Stem Cell Foundation Research Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Laura Andres-Martin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Stem Cell Foundation Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York Stem Cell Foundation Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Research Investigator', 'investigatorFullName': 'Laura Andres-Martin', 'investigatorAffiliation': 'New York Stem Cell Foundation Research Institute'}}}}