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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03331133
Other study ID # 2017060803
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2012
Est. completion date December 31, 2038

Study information

Verified date February 2024
Source Guangzhou Women and Children's Medical Center
Contact Xiu Qiu, PhD
Phone 0086 20 38367162
Email xiu.qiu@bigcs.org/qxiu0161@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The 2-BIG is a twin birth cohort study located in Guangzhou, China.Its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology. Data are collected regarding environmental, family and lifestyle exposures on twins from birth to 18 years old. Biological samples including blood and tissue samples are also collected from the twins and their parents.


Description:

Twins share the same intrauterine environment and the early family environment. When conducting research of chronic disease etiology, twins cohort can be a good control of bias from age, gender, genetic and early environment. Twin-based designs provide an estimate of the relative contribution of genetic and non-genetic factors to a specific phenotype. Twins study has an advantage of calculating heritability of traits. Since heritability of traits is various from different populations. It is important to establish database to calculate the heritability of traits associated with chronic major diseases in Chinese population. Twins cohort is rare in China at present. Therefore, extensive information including physical characteristics, mental health, and behaviors is collected from both twins and their parents. Longitudinal follow-up and surveillance of common diseases are also to be conducted. The 2-BIG aims to explore epigenetic markers and genes related to health status, as well as gene-environment interactions on diseases, both in intrauterine and childhood stages, especially in Chinese population.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2038
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: 1. Live twins delivered in Guangzhou Women and Children's Medical Center 2. Permanent residents or families intended to remain in Guangzhou with their children for no less than 3 years 3. Baseline information during pregnancy available

Study Design


Intervention

Other:
No intervention


Locations

Country Name City State
China Guangzhou Women and Children's Medical Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Guangzhou Women and Children's Medical Center

Country where clinical trial is conducted

China, 

References & Publications (1)

Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-02 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Neurodevelopment at early childhood Including adaptive, gross motor, fine motor, language, and social function; assessed using Gesell Developmental Schedules. At age of 1 year old
Primary Intelligence quotient Assessed using the Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition including 5 verbal and 3 performance subtests. Intelligence quotient ranges 40-160, in which under 70 is defined as mental retardation. The total score was calculated by an online system. At age of 6 years old
Primary Change of gene expression during childhood DNA methylation, histone acetylation etc. assessed by analyses of blood samples Age at 1 year , 6 years, 12years and 18years
Secondary Change of intestinal flora during early childhood Assessed by analyses of stool samples Age at 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years
Secondary Changes of body composition and bone density during early childhood Body composition and bone density are assessed using Dual Energy X-Ray Absorptiometry At birth, age of 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years
Secondary Height in kilometer changes during childhood Measured by nurses in clinic At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year
Secondary Weight in kilogram changes during childhood Measured by nurses in clinic At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year
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