Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-28 @ 12:59 AM
Study NCT ID:
NCT05218395
Status:
RECRUITING
Last Update Posted:
2022-02-24
First Post:
2022-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Persistent Organic Pollutants and Type 2 Diabetes /Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2022-01-20', 'lastUpdatePostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the risk of Persistent organic pollutant exposure to type 2 diabetes', 'timeFrame': '2021．11 Ethics Committee Approval 2021.12-2024.12 controls/patients recruitment, samples test 2025.1-2024.12 data analysis', 'description': 'to explore the effect of Persistent organic pollutant on the risk of type 2diabetes'}], 'secondaryOutcomes': [{'measure': 'To assess the risk of Persistent organic pollutant exposure to thyroid cancer', 'timeFrame': '2021．11 Ethics Committee Approval 2021.12-2024.12 controls/patients recruitment, samples test 2025.1-2024.12 data analysis', 'description': 'to explore the effect of Persistent organic pollutant on the risk of thyroid cancer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Thyroid Cancer', 'Organic Pollutant']}, 'descriptionModule': {'briefSummary': 'Persistent organic pollutants (POPs) are a class of organic pollutants in the environment characterized by persistent, bioaccumulation, long-range transport and biological toxicity. Due to its widespread distribution in the environment and Lipophilicity, POPs can bioaccumulate along the food chain and eventually accumulate in the human body. There are many types of POPs, including dioxins, polychlorinated biphenyls (PCBs) , polybrominated diphenyl ethers (PBDEs) and organochlorine pesticides (OCPs) . POPs is ubiquitous and Lipophilic in the environment, so the potential harm of POPs to human body has aroused wide concern. A growing number of studies have found that exposure to POPs may be associated with an increased risk of endocrine disease, particularly type 2 diabetes and thyroid cancer.\n\nThe aim of this study was to assess the effect of Persistent organic pollutant exposure on the development ofType 2 diabetes and thyroid cancer by analyzing serum Persistent organic pollutant concentrations in controls, and patients with Type 2 diabetes and thyroid cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study Population：18 \\~ 75 years old patients of type 2 diabetes，Thyroid Cancer and control。', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup of Type 2 diabetes patients:\n\n1. age 18 \\~ 75 years old;\n2. type 2 diabetes patients diagnosed in the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) , HBA1C ≥7.0% and \\<10.5% ;\n3. patients signed informed consent.\n\nGroup of Thyroid Cancer patients:\n\n1. age 18 \\~ 75 years old;\n2. thyroid cancer patients diagnosed in the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) ;\n3. patients who signed the informed consent form.\n\nControl Group:\n\n1. age 18 \\~ 75 years old;\n2. healthy population recruited from the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) ;\n3. living in the monitoring area for more than 6 months within 12 months;\n4. normal thyroid function and no history of thyroid cancer were needed in the control group;\n5. Fasting Blood Glucose level of 0.7 mmol/l was needed in the Control Group of Type 2 diabetes Mellitus Without History of diabetes;\n6. patients with informed consent.\n\nExclusion Criteria:\n\n* Group of Type 2 diabetes:\n\n (1) pregnant, lactating women, patients with acute cardiac cerebrovascular disease; (2) patients with severe liver and Renal Impairment (related laboratory tests more than 2 times the normal) ; (3) patients with Type 1 diabetes; (4) participants in other clinical trials within 3 months; (5) patients with malignant tumors. (6) has the disease and so on serious anemia, is not suitable to carry on the patient which the blood draws the test.\n\nGroup of Thyroid Cancer:\n\n1. patients with serious heart, liver and Kidney Diseases (related laboratory tests more than 2 times normal) ;\n2. patients with other malignant tumors.\n\nControl Group:\n\n1. patients with serious heart, liver or kidney disease;\n2. patients with iodine or Thyroid hormone;\n3. patients with confirmed malignant tumor;\n4. pregnant women or those who have recently taken contraception or estrogen.'}, 'identificationModule': {'nctId': 'NCT05218395', 'briefTitle': 'Association Between Persistent Organic Pollutants and Type 2 Diabetes /Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Association Between Persistent Organic Pollutants and Type 2 Diabetes /Thyroid Cancer', 'orgStudyIdInfo': {'id': 'YXLL-KY-2021(064)'}}, 'contactsLocationsModule': {'locations': [{'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoling Guan', 'role': 'CONTACT', 'email': 'gxlwho@163.com', 'phone': '8613356677195'}], 'facility': 'Xiaoling Guan', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Xiaoling Guan', 'role': 'CONTACT', 'email': 'gxlwho@163.com', 'phone': '8613356677195'}], 'overallOfficials': [{'name': 'Xiaoling Guan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qianfoshan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese Academy of Sciences', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}