Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT06203093
Status:
RECRUITING
Last Update Posted:
2025-03-03
First Post:
2024-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Charcot-Marie-Tooth Disease (CMT) Biological Sample Collection for IPSC Generation and Biobanking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002607', 'term': 'Charcot-Marie-Tooth Disease'}], 'ancestors': [{'id': 'D015417', 'term': 'Hereditary Sensory and Motor Neuropathy'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, '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': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2024-01-02', 'studyFirstSubmitQcDate': '2024-01-02', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biobank', 'timeFrame': 'Baseline', 'description': 'Establishment of a bank of stem cell lines and associated information to advance understanding of the biology, etiology, manifestations, progression, risk factors, genetic underpinnings, and treatment of Charcot-Marie-Tooth diseases.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Charcot-Marie-Tooth'], 'conditions': ['Charcot-Marie-Tooth Disease', 'Healthy']}, 'descriptionModule': {'briefSummary': 'The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate Charcot-Marie-Tooth disease research and drug development by using cells from the body (such as skin or blood cells) to make stem cells and other types of cells, conduct research on the samples, perform genetic testing, and/or store the samples for future use.\n\nThrough this research, researchers hope to identify future treatments or even cures for Charcot-Marie-Tooth disease.', 'detailedDescription': 'Researchers at the New York Stem Cell Foundation (NYSCF) Research Institute study diverse diseases, conditions, and traits by creating stem cells from biological samples. These "pluripotent" stem cells can become any cell in the human body, including cells that may be difficult, invasive, or impossible to obtain directly.\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 health questionnaires, (2) providing a skin and/or blood sample from which stem cells may be created, (3) collection of a saliva sample for genetic analysis, and (4) possible future followup 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'], 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with a Charcot-Marie-Tooth (CMT) diagnosis. Individuals without a condition to serve as healthy controls (a comparison group for CMT subjects).', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 5 years or older.\n* Diagnosis of Charcot-Marie-Tooth (CMT) disease or healthy controls.\n* Adults must provide written informed consent unless physical limitations preclude signing.\n* Minors undergoing skin collection for research purposes must have a CMT diagnosis and must participate with parent/guardian consent.\n* Minors undergoing blood and/or saliva collection for research purposes or who transfer biological samples from a procedure outside the research may have a CMT diagnosis or serve as a healthy control and may participate with parent/guardian consent.\n\nExclusion Criteria:\n\n* Wards of the state.\n* For prospective skin samples: history of keloid formation, coagulation disorder, allergy to the anesthetic, or anticoagulation use that precludes sample collection.\n* For prospective blood samples: coagulation disorder or other medical conditions that increase the risks associated with blood collection.\n* For all prospective sample collections: Subjects who refuse to adhere to NYSCF's and/or a collaborating site's safety protocols will be excluded. Subjects with an AIDS diagnosis and CD4 count of less than 200 cells per microliter of blood will be excluded due to increased risk of infection."}, 'identificationModule': {'nctId': 'NCT06203093', 'briefTitle': 'Charcot-Marie-Tooth Disease (CMT) Biological Sample Collection for IPSC Generation and Biobanking', 'organization': {'class': 'OTHER', 'fullName': 'New York Stem Cell Foundation Research Institute'}, 'officialTitle': 'Charcot-Marie-Tooth Disease (CMT) Biological Sample Collection for IPSC Generation and Biobanking', 'orgStudyIdInfo': {'id': '10-009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Charcot-Marie-Tooth Disease', 'description': 'Subjects in this group will have a diagnosis of Charcot-Marie-Tooth Disease.', 'interventionNames': ['Other: Biological Sample Collection']}, {'label': 'Healthy Control', 'description': 'Subjects in this group will serve as healthy controls.', 'interventionNames': ['Other: Biological Sample Collection']}], 'interventions': [{'name': 'Biological Sample Collection', 'type': 'OTHER', 'description': 'Skin biopsy (2-3mm) and/or blood (up to 50mL); saliva; excess/leftover biospecimens that were (or will be) collected for other purposes (e.g., medical procedure).', 'armGroupLabels': ['Charcot-Marie-Tooth Disease', 'Healthy Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Office', 'role': 'CONTACT', 'email': 'clinicalresearch@nyscf.org', 'phone': '212-927-1801'}], 'facility': 'New York Stem Cell Foundation Research Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Clinical Research Office', 'role': 'CONTACT', 'email': 'clinicalresearch@nyscf.org', 'phone': '212-927-1801'}], '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'}, 'collaborators': [{'name': 'Charcot-Marie-Tooth Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}