Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 12:30 AM
Study NCT ID:
NCT04984460
Status:
UNKNOWN
Last Update Posted:
2021-07-30
First Post:
2021-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Morphological Detection of Liquid-based Thin-layer Film-making Fungi for Fungal Vaginitis in Multiple Hospitals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014627', 'term': 'Vaginitis'}], 'ancestors': [{'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '10 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-22', 'studyFirstSubmitDate': '2021-07-22', 'studyFirstSubmitQcDate': '2021-07-22', 'lastUpdatePostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing the positive detection rate of 3/4 different detection methods in the first phase.', 'timeFrame': 'From Aug. 1st to Dec. 31st, 2021', 'description': 'The positive coincidence rate (sensitivity), negative coincidence rate (specificity) and total coincidence rate (consistency) was compared, according to the P\\<0.05 was used to determine whether it was statistically significant.'}, {'measure': 'Calculating the proportion of the number of fungi in three different states in the map results of three/four detection methods.', 'timeFrame': 'From Aug. 1st, 2021 to Jan. 31st, 2022', 'description': 'Counting The number and proportion of mycelia, spores and blastospores, especially the percentage of cases of single spore (+) in all cases of fungus (+).'}, {'measure': 'Counting the positive numbers of 4 or 6 liquid-based thin-layer fungal fluorescence morphological tests and fungal culture in the Stage 2_follow-up stage.', 'timeFrame': 'From Mar. 1, 2022 to Dec. 31st, 2022', 'description': 'the positive coincidence rate (sensitivity), negative coincidence rate (specificity) of 4 or 6 liquid-based thin-layer fungal fluorescence morphological tests'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluorescence morphological', 'liquid-based thin-layer film-making', 'Fungal vaginitis'], 'conditions': ['Vaginitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the results of different detection methods for non-gestational fungal vaginitis (VVC), and to evaluate the significance of different fungal states in the results for diagnosis and treatment.', 'detailedDescription': 'The study was divided into two phases: in the first phase, the vaginal secretions of 1000 enrolled patients with fungal vaginitis were detected with 3/4 different methods, and the sensitivity, specificity and consistency of these methods were compared; In the second stage, 1000 patients from the first stage were selected to meet the follow-up stage and divided into two groups. The test of Follow-up fungal culture and fluorescence morphological detection of liquid-based thin-layer film-making fungi were performed periodically. At last, the applicant will analyze the data, write the paper and publish the article.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '14 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients with suspected fungal vaginitis.', 'genderDescription': 'Fungal vaginitis is a disease that only women get.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Samples from outpatient or inpatient clinics to be tested for fungal vaginitis.\n* 2\\. A sample of one or more of the following characteristics. 2.1 Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased.\n\n2.2 Physical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd.\n\n* 3\\. The samples are vaginal secretions from the female body. Each sample should be the amount on one swab.\n* 4\\. The sample is not in menstrual period.\n* 5\\. The sample subjects did not have vaginal irrigation, medication or sexual intercourse within 3 days.\n\nExclusion Criteria:\n\n* 1\\. Cases with incomplete specimen collection;\n* 2\\. Mixed vaginitis cases;\n* 3\\. Abscission cases with incomplete follow-up.'}, 'identificationModule': {'nctId': 'NCT04984460', 'briefTitle': 'Morphological Detection of Liquid-based Thin-layer Film-making Fungi for Fungal Vaginitis in Multiple Hospitals', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital of Nantong University'}, 'officialTitle': 'A Multicenter Clinical Study on Liquid-based Morphological Detection of Fungi', 'orgStudyIdInfo': {'id': 'AHNantongU_YEZH_NTFS_V1.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'life-style counseling', 'description': 'A sample of one or more of the following characteristics. Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased.\n\nPhysical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd.', 'interventionNames': ['Diagnostic Test: Fluorescence morphological detection of liquid-based thin-layer film-making fungi']}], 'interventions': [{'name': 'Fluorescence morphological detection of liquid-based thin-layer film-making fungi', 'type': 'DIAGNOSTIC_TEST', 'description': 'Samples from outpatient or inpatient clinics to be tested for fungal vaginitis. A sample of one or more of the following characteristics. Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased.\n\nPhysical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd.\n\nSamples are human vaginal secretions. Each sample should be the amount on one swab.\n\nThe sample is not in menstrual period. The sample subjects did not have vaginal irrigation, medication or sexual intercourse within 3 days.', 'armGroupLabels': ['life-style counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230031', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hospital of Ustc', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Zhongshan', 'state': 'Guangdong', 'country': 'China', 'facility': "Zhongshan City People's Hospital", 'geoPoint': {'lat': 22.52306, 'lon': 113.37912}}, {'zip': '226001', 'city': 'Nantong', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Nantong University', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'zip': '226006', 'city': 'Nantong', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Affiliated Hospital of Nantong University', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'city': 'Nantong', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Affiliated Nantong Hospital Of Shanghai University', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'city': 'Nantong', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nantong Maternal and Child Health Hospital', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'city': 'Qidong', 'state': 'Jiangsu', 'country': 'China', 'facility': "Children's Hospital of Fudan University Qidong Branch", 'geoPoint': {'lat': 33.41667, 'lon': 119.21667}}, {'city': 'Jiujiang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'Jiujiang Maternal and Child Health Hospital', 'geoPoint': {'lat': 29.70475, 'lon': 116.00206}}, {'zip': '330006', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'Jiangxi Maternal and Child Health Hospital', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '200051', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Changning District Maternal and Child Health Care Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Yuquan Zhang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital of Nantong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not planning sharing at present.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Hospital of Nantong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Obstetrics and Gynaecology', 'investigatorFullName': 'Yuquan Zhang', 'investigatorAffiliation': 'Affiliated Hospital of Nantong University'}}}}