Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-29 @ 12:22 PM
Study NCT ID:
NCT05654857
Status:
UNKNOWN
Last Update Posted:
2023-08-16
First Post:
2022-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'stool specimen produced by normal excretion'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-14', 'studyFirstSubmitDate': '2022-12-08', 'studyFirstSubmitQcDate': '2022-12-08', 'lastUpdatePostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu', 'timeFrame': '2022.12.1-2023.6.30', 'description': 'the Helicobacter Pylori Infection rate in Jiangsu family'}], 'secondaryOutcomes': [{'measure': 'Trends of Antimicrobial Resistance of Helicobacter Pylori in Jiangsu', 'timeFrame': '2022.12.1-2023.6.30', 'description': 'resistance to antimicrobial agents applicable for H. pylori eradication'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resistance Mutation', 'Fecal Drug Resistance Gene Detection'], 'conditions': ['Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'To assess Family-unit Helicobacter Pylori Infection rates and antimicrobial resistance rates in Jiangsu,China', 'detailedDescription': 'The study is a sample survey of the community population in cities of Jiangsu where the centers are located.The Helicobacter pylori infection and drug-resistant gene mutations are detected by real-time PCR performed on the stools of subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study was a sample survey of the community population in each central lock-in area, rather than hospital patients.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. community population\n2. Fecal samples can be obtained, and the sample volume meets the requirements of the collection tube instructions\n3. Only one person per family can be selected\n4. Voluntarily participated in this study and signed an informed consent form\n\nExclusion Criteria:\n\n1. The collector does not cooperate or has poor compliance;\n2. Adequate and qualified fecal samples could not be obtained;\n3. Stool samples were collected during diarrhea or constipation;\n4. Antibiotics, bismuth preparations, proton pump inhibitors and other Hp sensitive drugs have been used within one month.'}, 'identificationModule': {'nctId': 'NCT05654857', 'briefTitle': 'The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu Based on Non-invasive PCR in Stool', 'orgStudyIdInfo': {'id': 'KY20221124-09'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PCR test in the stool', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will receive a prescription for a stool self-collection kit . Only the result of the PCR test in the stool will be considered for this arm. A positive test will determine Hp infection and the indication for treatment.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changzhou', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaofeng Ye', 'role': 'CONTACT', 'email': 'y13915066716@126.com', 'phone': '+86 13915066716'}, {'name': 'Xiaofeng Ye', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lu Shen', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Changzhou Traditional Chinese medical hospital,Affiliated to Nanjing University of Chinese Medicine', 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}, {'city': 'Huaian', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Wang', 'role': 'CONTACT', 'email': 'jhwangjun@126.com', 'phone': '+86 18915198177'}, {'name': 'Jun Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rong Ou', 'role': 'SUB_INVESTIGATOR'}], 'facility': "JinHu county people's hospital"}, {'city': 'Lianyungang', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shengxiang Lv', 'role': 'CONTACT', 'email': 'lvshengxiang2009@126.com', 'phone': '+86 18961320781'}, {'name': 'Shengxiang Lv', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zhimei Zhang, Zhang', 'role': 'SUB_INVESTIGATOR'}], 'facility': "The 1st people's hospital of Lianyungang", 'geoPoint': {'lat': 34.59845, 'lon': 119.21556}}, {'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenyu Zhang', 'role': 'CONTACT', 'email': 'zzy6565@sina.com', 'phone': '+86 025-87726248'}, {'name': 'Zhenyu Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bangshun He', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yunfan Dong', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wenjuan Wei', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Nanjing First Hospital, Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nantong', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Cuihua Lu', 'role': 'CONTACT', 'email': 'lch670608@sina.com', 'phone': '+86 13962801685'}, {'name': 'Cuihua Lu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hao Chen', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Affiliated Hospital of Nantong University', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'city': 'Nantong', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weibing Xu', 'role': 'CONTACT', 'email': 'xwbsy@sina.cn', 'phone': '+86 13773799779'}, {'name': 'Weibing Xu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jiawen Hong', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Rudong County People's Hospital", 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'city': 'Suqian', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhengyuan Xu', 'role': 'CONTACT', 'email': '2232469762@qq.com', 'phone': '+86 13951245858'}, {'name': 'Zhengyuan Xu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jiabing Wang', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Affiliated Shuyang Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 33.94917, 'lon': 118.29583}}, {'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaodan Xu', 'role': 'CONTACT', 'email': 'xxd20@163.com', 'phone': '+86 18913631835'}, {'name': 'Xiaodan Xu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ruifang Wang', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Changshu No.1 People's Hospital", 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Wuxi', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiang Zhan', 'role': 'CONTACT', 'email': 'zhanq33@163.com', 'phone': '+86 133 5811 1976'}, {'name': 'Qiang Zhan', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lixia Ding', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mindan Huang', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Department of Gastroenterology Wuxi People's Hospital Affiliated to Nanjing Medical University", 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'city': 'Xuzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guangxia Chen', 'role': 'CONTACT', 'email': 'gx_chen2010@163.com', 'phone': '+86 136 8513 5997'}, {'name': 'Guangxia Chen', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Min Liu', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xinxin Xu', 'role': 'SUB_INVESTIGATOR'}], 'facility': "The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University", 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'city': 'Yancheng', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianhua Cui', 'role': 'CONTACT', 'email': 'dtrmyycjh@163.com', 'phone': '+86 13905111556'}, {'name': 'Jianhua Cui', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lin Chen', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chong Chen', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Dongtai People's Hospital", 'geoPoint': {'lat': 33.3575, 'lon': 120.1573}}, {'city': 'Yancheng', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xundong Wu', 'role': 'CONTACT', 'email': 'lixiangsu39@126.com', 'phone': '+86 15861974719'}, {'name': 'Xundong Wu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiangsu Li', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Yancheng First Hospital Affiliated Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 33.3575, 'lon': 120.1573}}, {'city': 'Yangzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanbing Ding', 'role': 'CONTACT', 'email': 'ybding@yzu.edu.cn'}, {'name': 'Yanbing Ding', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zhaotao Duan', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Affiliated Hospital of Yangzhou University', 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}, {'city': 'Zhenjiang', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Xu', 'role': 'CONTACT', 'email': 'Peterxu1974@163.com', 'phone': '+86 15862990603'}, {'name': 'Min Xu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lamei Xu', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Han Jiang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sihui Wu', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Affiliated Hospital of Jiangsu University', 'geoPoint': {'lat': 32.21086, 'lon': 119.45508}}, {'city': 'Suzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Meijuan Xi', 'role': 'CONTACT', 'email': 'ximj333@126.com', 'phone': '+8613862318196'}, {'name': 'Jian Tao', 'role': 'CONTACT', 'phone': '+86 15995927193'}], 'facility': 'Changshu Hospital Affiliated to Nanjing University of Chinese Medicine', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Zhenjiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guiping Cui', 'role': 'CONTACT', 'email': 'yzcgp314007@sina.com', 'phone': '+86 18912118055'}, {'name': 'Bing Shi', 'role': 'CONTACT', 'phone': '+86 18912118048'}], 'facility': "People's hospital of Yangzhong City", 'geoPoint': {'lat': 32.21086, 'lon': 119.45508}}], 'centralContacts': [{'name': 'Zhenyu Zhang', 'role': 'CONTACT', 'email': 'zzy6565@sina.com', 'phone': '+86 025-87726248'}, {'name': 'Yunfan Dong', 'role': 'CONTACT', 'email': 'dyf967878@163.com', 'phone': '+86 18795993220'}], 'overallOfficials': [{'name': 'Zhenyu Zhang', 'role': 'STUDY_CHAIR', 'affiliation': 'Nanjing First Hospital, Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Gastroenterology', 'investigatorFullName': 'Zhenyu Zhang', 'investigatorAffiliation': 'Nanjing First Hospital, Nanjing Medical University'}}}}