Charcot-Marie-Tooth Disease (CMT) Biological Sample Collection for IPSC Generation and Biobanking
NCT ID: NCT06203093
Last Updated: 2025-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2022-09-22
2025-09-22
Brief Summary
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Through this research, researchers hope to identify future treatments or even cures for Charcot-Marie-Tooth disease.
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Detailed Description
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Additionally, 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.
Participation 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.
This study is not a clinical trial.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Charcot-Marie-Tooth Disease
Subjects in this group will have a diagnosis of Charcot-Marie-Tooth Disease.
Biological Sample Collection
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).
Healthy Control
Subjects in this group will serve as healthy controls.
Biological Sample Collection
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).
Interventions
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Biological Sample Collection
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).
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Charcot-Marie-Tooth (CMT) disease or healthy controls.
* Adults must provide written informed consent unless physical limitations preclude signing.
* Minors undergoing skin collection for research purposes must have a CMT diagnosis and must participate with parent/guardian consent.
* 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.
Exclusion Criteria
* For prospective skin samples: history of keloid formation, coagulation disorder, allergy to the anesthetic, or anticoagulation use that precludes sample collection.
* For prospective blood samples: coagulation disorder or other medical conditions that increase the risks associated with blood collection.
* 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.
5 Years
ALL
Yes
Sponsors
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Charcot-Marie-Tooth Association
OTHER
New York Stem Cell Foundation Research Institute
OTHER
Responsible Party
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Principal Investigators
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Laura Andres-Martin
Role: PRINCIPAL_INVESTIGATOR
New York Stem Cell Foundation Research Institute
Locations
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New York Stem Cell Foundation Research Institute
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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10-009
Identifier Type: -
Identifier Source: org_study_id
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