- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02681822
Multi-center Imaging Genetics Studies in China (CHIMGEN)
April 8, 2019 updated by: Chunshui Yu, Tianjin Medical University General Hospital
To study the impact of genetic and environmental factors on high-level cognition associated neural circuits among healthy young Chinese Han subjects.
Study Overview
Status
Unknown
Detailed Description
The investigators plan to collect behavioral assessment and environmental factors data,peripheral blood sample, MRI brain images in more than 10,000 healthy young Chinese Han individuals in order to build the pathway from gene to high-level cognitive phenotypes.
Study Type
Observational
Enrollment (Anticipated)
10000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300052
- Recruiting
- Tianjin Medical University General Hospital
-
Contact:
- Chunshui Yu, PhD
- Email: chunshuiyu@vip.163.com
-
Contact:
- Qiang Xu, PhD
- Email: xuqiang9042@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Healthy young Chinese Han subjects age 18-30
Description
Inclusion Criteria:
- aged 18-30
- Chinese Han
- right-handed
- without history of neuropsychiatric disease
- no substance addiction
- smoking
Exclusion Criteria:
- younger or elder than 18-30 year-old
- other ethnics
- with history of neuropsychiatric disease
- with history of neuropsychiatric disease among first,second and third degree relatives
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Healthy young subjects
Healthy young Chinese Han subjects aged 18-30
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain structure and function measured by MRI scans
Time Frame: 2 years
|
The participants will receive non-interventional multi-modal MRI scans, such as 3D-T1WI, DTI, DKI, ASL, REST-fmri, then the investigators can acquire the brain volume in region of interest, such as bilateral hippocampus.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Childhood adversities as assessed by Childhood Trauma Questionnaire-Short Form (Chinese Version)
Time Frame: 2 years
|
To investigate impact of the adversities in early life of participants on brain structure and function as well as the interaction effect of childhood adversities and genetic variations,such as 5-HTTLPR polymorphism.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Chunshui Yu, PhD, Tianjin Medical University General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Braskie MN, Jahanshad N, Stein JL, Barysheva M, McMahon KL, de Zubicaray GI, Martin NG, Wright MJ, Ringman JM, Toga AW, Thompson PM. Common Alzheimer's disease risk variant within the CLU gene affects white matter microstructure in young adults. J Neurosci. 2011 May 4;31(18):6764-70. doi: 10.1523/JNEUROSCI.5794-10.2011.
- Corder EH, Saunders AM, Strittmatter WJ, Schmechel DE, Gaskell PC, Small GW, Roses AD, Haines JL, Pericak-Vance MA. Gene dose of apolipoprotein E type 4 allele and the risk of Alzheimer's disease in late onset families. Science. 1993 Aug 13;261(5123):921-3. doi: 10.1126/science.8346443.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (ANTICIPATED)
December 1, 2019
Study Completion (ANTICIPATED)
December 1, 2020
Study Registration Dates
First Submitted
February 7, 2016
First Submitted That Met QC Criteria
February 11, 2016
First Posted (ESTIMATE)
February 12, 2016
Study Record Updates
Last Update Posted (ACTUAL)
April 10, 2019
Last Update Submitted That Met QC Criteria
April 8, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mood Disorders
- Neurocognitive Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Depressive Disorder
- Schizophrenia
- Alzheimer Disease
- Depressive Disorder, Major
Other Study ID Numbers
- 81425013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The investigators plan to share the IPD with the member institutes or hospitals after the total completion of the investigation.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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