Parkinson DiseaseNCT04270604
Biological Sample Collection for Research and Biobanking
An observational study of Parkinson Disease and Diabetes Mellitus, Type 1, run by New York Stem Cell Foundation Research Institute at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 1 month to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Diabetes Mellitus, Type 1, Macular Degeneration
- What is being tested?
- Biological sample collection
- How many people
- 1,279 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2012to 27 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Stem Cell Foundation Research Institute
New York, New York, 10019
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease, Diabetes Mellitus, Type 1, Macular Degeneration, ALS, Cancer, Alzheimer Disease
- Being tested
- Biological sample collection
- Keywords
- stem cell, observational, biobank, disease modeling, genetics
- Medical subject headings
- Parkinson Disease, Diabetes Mellitus, Type 1, Macular Degeneration, Neoplasms, Alzheimer Disease, Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sample collectionOther
Biological sample collection for biobanking and research
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start6 Feb 2012
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Why it stopped: The study was voluntarily terminated by the PI to focus efforts on an alternative biobanking protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,279 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Stem Cell Foundation Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Andres-Martin, New York Stem Cell Foundation Research Institute
- Investigators
- Laura Andres-Martin, Principal investigator, New York Stem Cell Foundation Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270604
- Sponsor's protocol ID
- 10-005
- Other IDs
- 20112091
- Status last verified
- Jul 2024
- First submitted
- 20 Dec 2019
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Sample Collection for Research and Biobanking
- ClinicalTrials.gov ID
- NCT04270604
- Acronym / sponsor ID
- 10-005
- Conditions
- Parkinson Disease, Diabetes Mellitus, Type 1, Macular Degeneration, ALS, Cancer, Alzheimer Disease
- Keywords
- stem cell, observational, biobank, disease modeling, genetics
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was voluntarily terminated by the PI to focus efforts on an alternative biobanking protocol.
- Enrolment
- 1,279 participants (actual)
- Lead sponsor
- New York Stem Cell Foundation Research InstituteUniversity, hospital or other
- Study start
- 6 Feb 2012 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- Age
- 18 years or older or
- Minor with parent/guardian consent
- Biological Sample Collection
- Able and willing to provide:
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological sample collectionBiological sample collection for biobanking and research | Other | – |
Primary outcome
Establishment of a diverse bank of biological samples, stem cell lines, derivatives, and associated information.
Time frame: Baseline
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.
Results and safety
The study was stopped early (reason given: The study was voluntarily terminated by the PI to focus efforts on an alternative biobanking protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- New York Stem Cell Foundation WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Andres-Martin principal investigator
New York Stem Cell Foundation Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Diabetes Mellitus, Type 1, run by New York Stem Cell Foundation Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was voluntarily terminated by the PI to focus efforts on an alternative biobanking protocol.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of a diverse bank of biological samples, stem cell lines, derivatives, and associated information. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.