Twin Diseases2-BIGNCT03331133
Twins Born in Guangzhou
An observational study of Twin Diseases and Immune Development, run by Guangzhou Women and Children's Medical Center at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Twin Diseases, Immune Development, Childhood Obesity
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2012to 31 Dec 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Twins delivered in Guangzhou, China and their parents
Who may be able to join
- Live twins delivered in Guangzhou Women and Children's Medical Center
- Permanent residents or families intended to remain in Guangzhou with their children for no less than 3 years
- Baseline information during pregnancy available
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623
Xiu Qiu, PhD, 0086 20 38367162, qxiu0161@163.com
About this study
Official title: Twins Born in Guangzhou Cohort Study
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.
Read the detailed 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.
- Conditions
- Twin Diseases, Immune Development, Childhood Obesity, Host and Microbiome, Neurodevelopment
- Being tested
- No intervention
- Keywords
- Twin, Early Development, Cohort
- Medical subject headings
- Diseases in Twins, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Identical Twins | Twins develop from one zygote with no intervention Receives: Other: No intervention | |
| Dizygotic Twins | Twins develop from two different zygote with no intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopment at early childhood
Including adaptive, gross motor, fine motor, language, and social function; assessed using Gesell Developmental Schedules.
Measured: At age of 1 year old
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.
Measured: At age of 6 years old
Change of gene expression during childhood
DNA methylation, histone acetylation etc. assessed by analyses of blood samples
Measured: Age at 1 year , 6 years, 12years and 18years
Secondary outcomes (4)
Change of intestinal flora during early childhood
Assessed by analyses of stool samples
Measured: Age at 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years
Changes of body composition and bone density during early childhood
Body composition and bone density are assessed using Dual Energy X-Ray Absorptiometry
Measured: At birth, age of 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years
Height in kilometer changes during childhood
Measured by nurses in clinic
Measured: At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year
Weight in kilogram changes during childhood
Measured by nurses in clinic
Measured: At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Feb 2012
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Twin DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiu Qiu, Guangzhou Women and Children's Medical Center
- Investigators
- Xiu Qiu, PhD, Principal investigator, Born in Guangzhou Cohort Study in Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331133
- Sponsor's protocol ID
- 2017060803
- Acronym
- 2-BIG
- Status last verified
- Feb 2024
- First submitted
- 20 Oct 2017
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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/s10654-017-0239-x. Epub 2017 Mar 20.
PubMed 28321694
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twins Born in Guangzhou Cohort Study
- ClinicalTrials.gov ID
- NCT03331133
- Acronym / sponsor ID
- 2-BIG / 2017060803
- Conditions
- Twin Diseases, Immune Development, Childhood Obesity, Host and Microbiome, Neurodevelopment
- Keywords
- Twin, Early Development, Cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 6 Nov 2017 (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 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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Identical Twins | – | Other: No interventionTwins develop from one zygote with no intervention |
| Dizygotic Twins | – | Other: No interventionTwins develop from two different zygote with no intervention |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Twins delivered in Guangzhou, China and their parents
Key inclusion criteria (3 listed)
- Live twins delivered in Guangzhou Women and Children's Medical Center
- Permanent residents or families intended to remain in Guangzhou with their children for no less than 3 years
- Baseline information during pregnancy available
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| No intervention | Other | Dizygotic Twins, Identical Twins |
Primary outcome
Neurodevelopment at early childhood
Time frame: At age of 1 year old
Including adaptive, gross motor, fine motor, language, and social function; assessed using Gesell Developmental Schedules.
Intelligence quotient
Time frame: At age of 6 years old
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.
Change of gene expression during childhood
Time frame: Age at 1 year , 6 years, 12years and 18years
DNA methylation, histone acetylation etc. assessed by analyses of blood samples
4 secondary outcomes
Change of intestinal flora during early childhood
Time frame: Age at 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years
Changes of body composition and bone density during early childhood
Time frame: At birth, age of 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years
Height in kilometer changes during childhood
Time frame: At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year
Weight in kilogram changes during childhood
Time frame: At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Results publication: PubMed 28321694Qiu 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/s10654-017-0239-x. Epub 2017 Mar 20.
- Related websiteLink provided by the sponsor.
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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.
Xiu Qiu, PhD principal investigator
Born in Guangzhou Cohort Study in Guangzhou Women and Children's Medical Center
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 Twin Diseases and Immune Development, run by Guangzhou Women and Children's Medical Center at 1 site in China.
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 3 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 26 Feb 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiu Qiu, PhD (0086 20 38367162, xiu.qiu@bigcs.org/qxiu0161@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurodevelopment at early childhood (time frame: At age of 1 year old). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03331133, which also lists 1 linked publication.
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 26 Feb 2024; AzTrials last refreshed its copy on 31 Oct 2026.