Biological Sample Collection for Research and Biobanking

Cancer Clinical Trial

Official title:

Biological Sample Collection for Research and Biobanking

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04270604
• Other study ID #: 10-005
• Secondary ID: 20112091
• Status: Active, not recruiting
• Start date: February 6, 2012
• Est. completion date: January 2030

Study information

• Verified date: March 2023
• Source: New York Stem Cell Foundation Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1279
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• ALS
• Alzheimer Disease
• Cancer
• Diabetes Mellitus, Type 1
• Huntington Disease
• Macular Degeneration
• Parkinson Disease

Intervention

Other:
• Biological sample collection
Biological sample collection for biobanking and research

Locations

Country	Name	City	State
United States	New York Stem Cell Foundation Research Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York Stem Cell Foundation Research Institute	Laser and Skin Surgery Center of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishment of a diverse bank of biological samples, stem cell lines, derivatives, and associated information.	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.	Baseline

External Links

•   New York Stem Cell Foundation Website