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The Born in Guangzhou Cohort Study (BIGCS) (BIGCS)
This study is currently recruiting participants.
Verified August 2015 by Xiu Qiu, Guangzhou Women and Children's Medical Center
Sponsor:
Guangzhou Women and Children's Medical Center
Collaborator:
University of Birmingham
Information provided by (Responsible Party):
Xiu Qiu, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier:
NCT02526901
First received: August 13, 2015
Last updated: August 16, 2015
Last verified: August 2015
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 13, 2015 | ||||||||
| Last Updated Date | August 16, 2015 | ||||||||
| Start Date ICMJE | February 2012 | ||||||||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Number of participant with pregnancy outcomes [ Time Frame: At delivery ] Including abortion, stillbirth, live birth, preterm birth, low birth weight and birth defects |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Born in Guangzhou Cohort Study (BIGCS) | ||||||||
| Official Title ICMJE | The Born in Guangzhou Cohort Study (BIGCS) | ||||||||
| Brief Summary | The Born in Guangzhou Cohort Study (BIGCS) was established to investigate the short- and long-term effects of exposure in early life on health consequences in Guangzhou, China. Data are collected regarding environmental, occupational and lifestyle exposures as well as health outcomes in later life. Biological samples including blood and tissue samples are also collected from the participants. | ||||||||
| Detailed Description | Over the past three decades, China is undergoing rapidly economic development. At the same time, the Western diet and urban lifestyle has been more common than before, which may lead to an increase of incidence of non-communicable chronic diseases, such as diabetes and malignancies. Notably, the current generation of Chinese adults, particularly those in their middle age or older, were born in an era where hardship and rationing was the norm and witnessed a social and epidemiological transition that might have a profound effect on their present health. In contrast, the younger generation is raised in relative material abundance, under the influence of traditional Chinese values such as a strong family orientation and an emphasis on academic success. A birth cohort with would provide an opportunity to examine the short- and long-term effects of exposure in early life on health consequences in this younger generation, in the context of rapid development in China. | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: During pregnancy: maternal blood, urine and stool. At delivery: cord, cord blood and placenta. During infancy: dry blood spot, stool and blood. Druing childhood: blood, buccal swab and stool. |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Pregnant women attending their first routine antenatal examinations (usually around week 16) and their partners and offsrping | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Other: No intervention | ||||||||
| Study Groups/Cohorts | No treatment
Intervention: Other: No intervention |
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| Publications * | He JR, Yuan MY, Chen NN, Lu JH, Hu CY, Mai WB, Zhang RF, Pan YH, Qiu L, Wu YF, Xiao WQ, Liu Y, Xia HM, Qiu X. Maternal dietary patterns and gestational diabetes mellitus: a large prospective cohort study in China. Br J Nutr. 2015 Apr 28;113(8):1292-300. doi: 10.1017/S0007114515000707. Epub 2015 Mar 30. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30000 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Senior | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT02526901 | ||||||||
| Other Study ID Numbers ICMJE | 2011Y2-00025 201041-E00741 ( Other Grant/Funding Number: Guangzhou Science and Technology Bureau, Guangzhou, China ) 2012J5100038 ( Other Grant/Funding Number: Guangzhou Science and Technology Bureau, Guangzhou, China ) 201508030037 ( Other Grant/Funding Number: Guangzhou Science and Technology Bureau, Guangzhou, China ) |
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| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Xiu Qiu, Guangzhou Women and Children's Medical Center | ||||||||
| Study Sponsor ICMJE | Guangzhou Women and Children's Medical Center | ||||||||
| Collaborators ICMJE | University of Birmingham | ||||||||
| Investigators ICMJE |
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| PRS Account | Guangzhou Women and Children's Medical Center | ||||||||
| Verification Date | August 2015 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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