Clinical trial NCT04270604: Biological Sample Collection for Research and Biobanking
Official title: Biological Sample Collection for Research and Biobanking
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Parkinson Disease
Diabetes Mellitus, Type 1
Macular Degeneration
ALS
Cancer
Alzheimer Disease
Huntington Disease
Keywords: stem cell
observational
biobank
disease modeling
genetics
Lead sponsor: New York Stem Cell Foundation Research Institute
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 1279
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with a diagnosis of one or more of the listed conditions.

Individuals with a known genetic mutation, with or without a diagnosed condition.

Individuals without a genetic mutation or condition to serve as healthy controls (a comparison group for those with conditions).

Brief summary: 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.

Through this research, scientists hope to identify future treatments or even cures.

Detailed description: 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.

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 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.

This study is not a clinical trial.

Eligibility criteria: Inclusion Criteria:

Age

* 18 years or older or
* Minor with parent/guardian consent

Biological Sample Collection

* Able and willing to provide:

  * new samples of blood, skin, and/or saliva specifically for use in this study and/or
  * excess/leftover samples, cell lines, and/or derivatives that were (or will be) collected for reasons other than this study

Exclusion Criteria:

* Non-English speaking
* Wards of the state
* 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.
* 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.
* For saliva samples: inability to produce sufficient saliva or has a condition that precludes sample collection (such as severe trismus).
* For prospective samples: refuse to adhere to NYSCF's and/or collaborating site's COVID-19 safety protocols during the COVID-19 pandemic.

Primary outcomes:
measure: Establishment of a diverse bank of biological samples, stem cell lines, derivatives, and associated information.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Stem Cell Foundation Research Institute
state: New York
Study officials:
affiliation: New York Stem Cell Foundation Research Institute
name: Laura Andres-Martin
role: PRINCIPAL_INVESTIGATOR
References: