Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT04953533
Status:
UNKNOWN
Last Update Posted:
2021-07-08
First Post:
2021-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Research and Development of a New Technology for Detection of Abnormal Excretion of Intestinal Uric Acid Involved in the Incidence of Gout
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}, {'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'for specific SNP and intestinal microflora'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-06', 'studyFirstSubmitDate': '2021-03-16', 'studyFirstSubmitQcDate': '2021-07-06', 'lastUpdatePostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the difference of the specific Single Nucleotide Polymorphisms(SNPs)', 'timeFrame': '2021.1.6--2021.12.31', 'description': 'We will test the specific SNPs that we have selected before, such as rs670, rs671, rs1014290 and so on. The SNPs will be tested by Taqman SNP assay and verified by sequencing.'}, {'measure': 'intestinal flora', 'timeFrame': '2021.1.6--2022.12.31', 'description': 'Feces will be collected in gout, hyperuricemia patients and healthy subjects. ofIntestinal flora will be tested and analysed. The detailed measurement is as follows: Firstly, the DNA of feces will be extracted according to the protocol of Fecal DNA Extraction Kit. Then, the concentration and purity of fecal DNA will be tested by spectrophotometer. Sequencing of the V3-V4 region of the 16S ribosomal RNA gene, building a library and then sequencing the qualified libraries by Illumina Platform(MiSeq). Using the QIIME、UCLUST、SILVA and Kyoto Encyclopedia of Genes and Genomes(KEGG) database to comparison and screen the intestinal bacterial with statistical significance. Operational taxonomic unit (OTU), α-diversity, β-diversity indices and so on of the fecal microbiota will be analyzed in patients with gout and hyperuricemia and normal control.'}, {'measure': 'feces uric acid level', 'timeFrame': '2021.1.6--2.22.12.31', 'description': 'Feces uric acid level will be tested by uric acid assay kit and we will analyze the differences of feces uric acid level in gout, hyperuricemia patients and healthy subjects.'}], 'secondaryOutcomes': [{'measure': 'the incidence of gout in patients with hyperuricemia', 'timeFrame': '2021.12.31--2023.12.31', 'description': 'follow-up the patients with hyperuricemia for at least one year, calculate the incidence of hyperuricemia patients develop to gout.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gout', 'Hyperuricemia', 'Gut Microbiota', 'Uric Acid', 'Genetic Loci', 'Single Nucleotide Polymorphism', 'Feces']}, 'descriptionModule': {'briefSummary': 'To evaluate differences in specific SNPs and intestinal microflora between patients with gout and hyperuricemia and healthy controls.', 'detailedDescription': '1. To evaluate differences in specific SNPs and intestinal microflora between patients with gout and hyperuricemia and healthy controls.\n2. to measure the level of uric acid in feces.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'gout，hyperuricemia and healthy controls in our hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'gout\n\nInclusion Criteria:\n\n1. age:year of 25\\~60;\n2. Be consistent with the 2015 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) gout diagnostic criteria ,and serum uric acid \\>420 μmol/L;\n3. The patient are willing to take part in our study.\n\nExclusion Criteria:\n\n1. abronia, surgery, postoperative, dehydration within 2 weeks, acute or chronic infectious diseases, severe trauma, malnutrition, diabetes, malignant tumors;\n2. diagnosed as cardiovascular and cerebrovascular diseases within 3 months;\n3. heart failure (New York Heart Academy，grade IV);\n4. hepatic insufficiency ( Alanine transaminase or Aspartate aminotransferase ≥3×upper limit)；\n5. chronic kidney disease or abnormal renal function( serum creatinine ≥1.5×upper limit)；\n6. excessive drinking；\n7. The investigators considered the patients unsuitable for inclusion in this study.\n\nhyperuricemia:\n\nInclusion Criteria:\n\n1. age:year of 25\\~60;\n2. A medical record in our hospital showed that the person is healthy, without key disease;\n3. serum uric acid \\>420μmol/L without gout flares. Exclusion Criteria:Same as the group of gout.\n\nhealthy controls:\n\nInclusion Criteria:\n\nage:year of 25\\~60; A medical record in our hospital showed that the person is healthy, without key disease; serum uric acid ≤420μmol/L. Exclusion Criteria:Same as the group of gout.'}, 'identificationModule': {'nctId': 'NCT04953533', 'briefTitle': 'Research and Development of a New Technology for Detection of Abnormal Excretion of Intestinal Uric Acid Involved in the Incidence of Gout', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Research on New Technologies for Diagnosis and Treatment of Skin Diseases and Venereal Diseases and Rheumatoid Diseases-- Research and Development of a New Technology for Detection of Abnormal Excretion of Intestinal Uric Acid Involved in the Incidence of Gout', 'orgStudyIdInfo': {'id': '2020C03044'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with gout', 'description': '1. age:year of 25\\~60;\n2. consistent with the 2015 ACR gout diagnostic criteria ,and serum uric acid \\>420umol/L;\n3. The patient are willing to take part in our study.', 'interventionNames': ['Other: no intervention']}, {'label': 'patients with hyperuricemia', 'description': '1. age:year of 25\\~60;\n2. A medical record in our hospital showed that the person is healthy, without key disease;\n3. serum uric acid \\>420umol/L without gout flares.', 'interventionNames': ['Other: no intervention']}, {'label': 'healthy controls', 'description': '1. age:year of 25\\~60;\n2. A medical record in our hospital showed that the person is healthy, without key disease;\n3. serum uric acid ≤420umol/L.', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'armGroupLabels': ['healthy controls', 'patients with gout', 'patients with hyperuricemia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huaxiang Wu, PHD', 'role': 'CONTACT', 'email': 'wuhx8855@sina.com', 'phone': '13757118395'}], 'facility': 'the second affliated hospital of Zhejiang university School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Huaxiang Wu, PHD', 'role': 'CONTACT', 'email': 'wuhx8855@sina.com', 'phone': '13757118395'}], 'overallOfficials': [{'name': 'Xiaoyong Liu, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Zhejiang University School of Medicine'}, {'name': 'Lei Liu, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Second Affiliated Hospital of Zhejiang University School of Medicine'}, {'name': 'Peiyu Zhang, MFA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang university,'}, {'name': 'Mo Chen, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Zhejiang University School of Medicine'}, {'name': 'Jundi Wang, bachelor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang university,'}, {'name': 'Shunjie Hu, bachelor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang university,'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'For the time being, we decided not to share individual participant data with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}