Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-01-09 @ 7:33 AM
Study NCT ID:
NCT03331133
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2017-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Twins Born in Guangzhou
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004200', 'term': 'Diseases in Twins'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'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 During childhood: blood, buccal swab and stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2038-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2017-10-20', 'studyFirstSubmitQcDate': '2017-10-31', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurodevelopment at early childhood', 'timeFrame': 'At age of 1 year old', 'description': 'Including adaptive, gross motor, fine motor, language, and social function; assessed using Gesell Developmental Schedules.'}, {'measure': 'Intelligence quotient', 'timeFrame': 'At age of 6 years old', 'description': '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.'}, {'measure': 'Change of gene expression during childhood', 'timeFrame': 'Age at 1 year , 6 years, 12years and 18years', 'description': 'DNA methylation, histone acetylation etc. assessed by analyses of blood samples'}], 'secondaryOutcomes': [{'measure': 'Change of intestinal flora during early childhood', 'timeFrame': 'Age at 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years', 'description': 'Assessed by analyses of stool samples'}, {'measure': 'Changes of body composition and bone density during early childhood', 'timeFrame': 'At birth, age of 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years', 'description': 'Body composition and bone density are assessed using Dual Energy X-Ray Absorptiometry'}, {'measure': 'Height in kilometer changes during childhood', 'timeFrame': 'At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year', 'description': 'Measured by nurses in clinic'}, {'measure': 'Weight in kilogram changes during childhood', 'timeFrame': 'At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year', 'description': 'Measured by nurses in clinic'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Twin', 'Early Development', 'Cohort'], 'conditions': ['Twin Diseases', 'Immune Development', 'Childhood Obesity', 'Host and Microbiome', 'Neurodevelopment']}, 'referencesModule': {'references': [{'pmid': '28321694', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.bigcs.com.cn', 'label': 'Related website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Twins delivered in Guangzhou, China and their parents', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Live twins delivered in Guangzhou Women and Children's Medical Center\n2. Permanent residents or families intended to remain in Guangzhou with their children for no less than 3 years\n3. Baseline information during pregnancy available"}, 'identificationModule': {'nctId': 'NCT03331133', 'acronym': '2-BIG', 'briefTitle': 'Twins Born in Guangzhou', 'organization': {'class': 'OTHER', 'fullName': "Guangzhou Women and Children's Medical Center"}, 'officialTitle': 'Twins Born in Guangzhou Cohort Study', 'orgStudyIdInfo': {'id': '2017060803'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Identical Twins', 'description': 'Twins develop from one zygote with no intervention', 'interventionNames': ['Other: No intervention']}, {'label': 'Dizygotic Twins', 'description': 'Twins develop from two different zygote with no intervention', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'armGroupLabels': ['Dizygotic Twins', 'Identical Twins']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510623', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiu Qiu, PhD', 'role': 'CONTACT', 'email': 'qxiu0161@163.com', 'phone': '0086 20 38367162'}], 'facility': "Guangzhou Women and Children's Medical Center", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xiu Qiu, PhD', 'role': 'CONTACT', 'email': 'xiu.qiu@bigcs.org/qxiu0161@163.com', 'phone': '0086 20 38367162'}, {'name': 'Xuan Zhao, MSc', 'role': 'CONTACT', 'email': 'xuan.zhao@bigcs.org', 'phone': '0086 20 38367159'}], 'overallOfficials': [{'name': 'Xiu Qiu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Born in Guangzhou Cohort Study in Guangzhou Women and Children's Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangzhou Women and Children's Medical Center", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Born in Guangzhou Cohort Study', 'investigatorFullName': 'Xiu Qiu', 'investigatorAffiliation': "Guangzhou Women and Children's Medical Center"}}}}