NCT03633162

Brief Summary

The MGBIG is a study exploring cross-generational effects in 5000 women and their children and grandchildren located in Guangzhou, China. Its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology and on explaining the cause of the disease from the perspective of "grandmother-mother-child" heredity. Data are collected regarding environmental exposures, lifestyle, and social support on grandmother from birth to old age. Biological samples including blood and tissue samples are collected.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
154mo left

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
May 2018Dec 2038

Study Start

First participant enrolled

May 21, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
13 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2038

Expected
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

7.6 years

First QC Date

July 23, 2018

Last Update Submit

September 27, 2024

Conditions

Keywords

Maternal GrandmotherGenesImmuneCohortChild development

Outcome Measures

Primary Outcomes (1)

  • Haplotypes transfered by non-inherited maternal antigens from maternal grandmother to female offspring

    Assessed by analyses of MHC haplotypes, HLA haplotypes, and levels of non-inherited maternal antigens of mother and offspring, and pregnancy complication of maternal grandmothers and mothers

    From the date of her daughter get pregnant until the date her grandchild/grandchildren is/are given birth

Secondary Outcomes (7)

  • Serum levels of Inflammatory factors at grandchildren's birth and early neonatal life

    At the birth date of her grandchild/grandchildren, at the date 42 days after the birth of the certain grandchild/grandchildren

  • The prevalence of eczema of grandchildren

    At the age of 6 weeks, 6 months, 1year, 3 years, 6 years, 12years and 18years of grandchildren

  • The incidence of asthma of grandchildren

    At the age of 6 months, 1year, 3 years, 6 years, 12years and 18years of grandchildren

  • The prevalence of Allergic rhinitis of grandchildren

    At the age of 6 months, 1year, 3 years, 6 years, 12years and 18years of grandchildren

  • The prevalence of Food allergy of children and grandchildren

    At the age of 6 months, 1year, 3 years, 6 years, 12years and 18years of grandchildren

  • +2 more secondary outcomes

Eligibility Criteria

Age36 Years - 100 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All maternal grandmothers of the children in the Born in Guangzhou Cohort Study (BIGCS) would be recruited.

You may qualify if:

  • Maternal Grandmother' grandchildren delivered in Guangzhou Women and Children's Medical Center
  • Baseline information of maternal grandmother's daughter during pregnancy available

You may not qualify if:

  • Significant cardiovascular abnormalities
  • Intelligent obstacle, intellectual disabilities or gawkish condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510623, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28321694BACKGROUND
  • Kinder JM, Jiang TT, Ertelt JM, Xin L, Strong BS, Shaaban AF, Way SS. Cross-Generational Reproductive Fitness Enforced by Microchimeric Maternal Cells. Cell. 2015 Jul 30;162(3):505-15. doi: 10.1016/j.cell.2015.07.006. Epub 2015 Jul 23.

    PMID: 26213383BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood, buccal mucosal cells, stool, urine, fingernail and hair

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Xiu Qiu, PhD

    Guangzhou Women and Children's Medical Center, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Born in Guangzhou Cohort Study

Study Record Dates

First Submitted

July 23, 2018

First Posted

August 16, 2018

Study Start

May 21, 2018

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2038

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations