Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-01-07 @ 1:34 PM
Study NCT ID:
NCT04694495
Status:
COMPLETED
Last Update Posted:
2025-06-27
First Post:
2021-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HPV Infection and Genital Microecology of Childbearing-age Female in China: A Cohort and Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Biospecimen will include cervical and vaginal swabs, cervical exfoliated cells from reproductive tract of the volunteers'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2021-01-03', 'studyFirstSubmitQcDate': '2021-01-03', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'alteration of genital microecology from baseline at month 6', 'timeFrame': 'basline and month 6', 'description': 'Genital microecology includes measurements of cervical microbiota, HPV and other sexually transmitted diseases pathogens infection status, conditions of the vaginal secretion and the grade of cervical intraepithelial neoplasia. As for cervical microbiota, the NGS technology will be used to sequence the 16s rRNA gene of the microbes in the cervical secretion of each volunteers. PCR will be used to detect HPV and other sexually transmitted diseases pathogens. As for the conditions of the vaginal secretion, methods such as manual microscopic inspection, gram stain and enzymology test will be used to do the measurement. Moreover, thinprep cytologic test of cervical exfoliated cells will be performed to evaluate the grade of cervical intraepithelial neoplasia.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Papillomavirus Infections', 'Uterine Cervical Neoplasms', 'Sexual Transmitted Disease']}, 'referencesModule': {'references': [{'pmid': '41238551', 'type': 'DERIVED', 'citation': 'Chen M, Qi C, Qing W, Zhou Z, Zhang Y, Chen R, Hou Y, Ou J; CALM2004 Consortium Investigators; He Y, Zhou H. Vaginal microbiome and sexually-transmitted pathogens in Chinese reproductive-age women: a multicentre cross-sectional and longitudinal cohort study. Nat Commun. 2025 Nov 14;16(1):10002. doi: 10.1038/s41467-025-64917-7.'}, {'pmid': '39468466', 'type': 'DERIVED', 'citation': 'Zhang Y, Qing W, Mo W, Chen R, Zhou Z, Hou Y, Shi Y, Qi C, Ou J, Xie L; CALM 2004 Study Group; Wang Y, Zhou H, Chen M. U. Parvum serovars exhibit distinct pathogenicity in Chinese women of childbearing age: a multicentre cross-sectional study. BMC Infect Dis. 2024 Oct 28;24(1):1213. doi: 10.1186/s12879-024-10113-9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study to access the relations between genital microecology, HPV infection and cervical intraepithelial neoplasia of childbearing-age female in China', 'detailedDescription': "The volunteers will be recruited from the women who come to the hospital to do the thinprep cytologic test. After being informed about the potential risks, each volunteer giving written informed consent will be asked to complete a questionnaire. Then, cervical and vaginal swabs and cervical exfoliated cells will be taken from each volunteer to perform 16S rRNA gene sequencing microecology assessment on cervical secretions and detection and genotyping of HPV and pathogens of sexually transmitted diseases. If there is something abnormal with the diagnostic outcomes in the previous examinations, according to the doctor's judgement, those volunteer will be asked to undergo a vaginoscope and a cervical biopsy to evaluate the grade of cervical intraepithelial neoplasia. After six months since the entry, each volunteer will be asked to go back to each research center to do the same sampling and examination as previously did in entry."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Volunteers will be recruited from both outpatient department of gynecology and health examination center in each research center', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female of childbearing age conducting thinprep cytologic test\n* Having an experience of sexual intercourse\n* Not during the menstrual period\n* No sexual intercourse or vaginal medication or vaginal flushing in 3 days before sampling\n\nExclusion Criteria:\n\n* Within 8 weeks of pregnancy or postpartum\n* Having had tumors in reproductive tract\n* Having had HPV bivalent, tetravalent or nine-valent vaccination\n* Having received treatment for anti- HPV or other STDs pathogens infection\n* Having had hysterectomy, cervical surgery and pelvic radiotherapy\n* Having used broad-spectrum antibiotics, probiotics or vaginal suppositories in reproductive tract within 1 month'}, 'identificationModule': {'nctId': 'NCT04694495', 'briefTitle': 'HPV Infection and Genital Microecology of Childbearing-age Female in China: A Cohort and Multicenter Study', 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'officialTitle': 'HPV Infection and Genital Microecology of Childbearing-age Female in China: A Cohort and Multicenter Study', 'orgStudyIdInfo': {'id': 'CALM2004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'volunteers from health examination center', 'description': 'volunteers(n = 50/center) doing gynecologial examination recruited from health examination center, who shows no symptoms and signs in reproductive tract and are potentially regarded as the healthy controls', 'interventionNames': ['Diagnostic Test: 16S rRNA gene sequencing of cervical secretions']}, {'label': 'volunteers from gynecology outpatient', 'description': 'volunteers(n = 150/center) recruited from gynecology outpatient, who show abnormal symptoms and signs in reproductive tract and are potentially regarded as the cases with conditions in reproductive tract', 'interventionNames': ['Diagnostic Test: 16S rRNA gene sequencing of cervical secretions']}], 'interventions': [{'name': '16S rRNA gene sequencing of cervical secretions', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Microecology assessment of cervical secretions', 'Genotyping of HPV and detection of sexually transmitted diseases pathogens', 'Thinprep cytologic test of cervical exfoliated cells'], 'description': '1. 16S rRNA gene sequencing of vaginal secretions: using NGS technology to assess the microbiota of the vaginal secretions\n2. Microecology assessment of vaginal secretions: morphology test, functional assessment and Nugent score assessment of the vaginal secretions are included.\n3. Genotyping of HPV and detection of sexually transmitted diseases pathogens based on the cervical exfoliated cells\n4. Thinprep cytologic test of cervical exfoliated cells: to evaluate the grade of cervical intraepithelial neoplasia', 'armGroupLabels': ['volunteers from gynecology outpatient', 'volunteers from health examination center']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hospital of USTC', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Lanzhou', 'state': 'Gansu', 'country': 'China', 'facility': 'The First Hospital of Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'city': 'Chaozhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Chaozhou Central Hospital', 'geoPoint': {'lat': 23.65396, 'lon': 116.62262}}, {'city': 'Dongguan', 'state': 'Guangdong', 'country': 'China', 'facility': "Dongguan People's Hospital", 'geoPoint': {'lat': 23.01797, 'lon': 113.74866}}, {'city': 'Foshan', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong Provincial Hospital of Intergrated Traditional Chinese and Western Medicine', 'geoPoint': {'lat': 23.02677, 'lon': 113.13148}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhujiang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Taihe Branch of Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Jinan University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The Third Affiliated Hospital of Guangzhou University of Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The Third Affiliated Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Huizhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Huizhou Municipal Central Hospital', 'geoPoint': {'lat': 23.11147, 'lon': 114.41523}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'Peking University Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'Shenzhen Hospital of Guangzhou University of Chinese Medicine', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': "Shenzhen Luohu Hospital Group Luohu People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'The Seventh Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': "The Third People's Hospital of Shenzhen", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Zhongshan', 'state': 'Guangdong', 'country': 'China', 'facility': "Xiaolan People's Hospital of Zhongshan", 'geoPoint': {'lat': 22.52306, 'lon': 113.37912}}, {'city': 'Guangzhou', 'state': 'Guangzhou', 'country': 'China', 'facility': 'The First Affiliated Hospital, Sun Yat-Sen Univeristy', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Zhuhai', 'state': 'Guangzhou', 'country': 'China', 'facility': "Zhuhai Women and Children's Hospital", 'geoPoint': {'lat': 22.27694, 'lon': 113.56778}}, {'city': 'Guiyang', 'state': 'Guizhou', 'country': 'China', 'facility': 'The Affiliated Hospital of Guizhou Medical University', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'city': 'Zunyi', 'state': 'Guizhou', 'country': 'China', 'facility': "The First People's Hospital of Zunyi", 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}, {'city': 'Shaoguan', 'state': 'Gunagdong', 'country': 'China', 'facility': "Yue Bei People's Hospital", 'geoPoint': {'lat': 24.8, 'lon': 113.58333}}, {'city': 'Haikou', 'state': 'Hainan', 'country': 'China', 'facility': 'Hainan General Hospital', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The Second Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Qiqihar', 'state': 'Hei Longjiang', 'country': 'China', 'facility': 'The First Hospital fo Qiqihar', 'geoPoint': {'lat': 47.33922, 'lon': 123.96154}}, {'city': 'Lianyungang', 'state': 'Jiangsu', 'country': 'China', 'facility': "The Second People's Hospital of Lianyungang", 'geoPoint': {'lat': 34.59845, 'lon': 119.21556}}, {'city': 'Jilin', 'state': 'Jilin', 'country': 'China', 'facility': 'Jilin Central General Hospital', 'geoPoint': {'lat': 43.84652, 'lon': 126.5608}}, {'city': 'Yinchuan', 'state': 'Ningxia', 'country': 'China', 'facility': 'General Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}, {'city': 'Xining', 'state': 'Qinghai', 'country': 'China', 'facility': 'Qinghai Red Cross Hospital', 'geoPoint': {'lat': 36.62554, 'lon': 101.75739}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Jinan Central Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Obstetrics&Gynecology Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Changzhi', 'state': 'Shanxi', 'country': 'China', 'facility': "Changzhi People's Hospital", 'geoPoint': {'lat': 36.18389, 'lon': 113.10528}}, {'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': "The First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'city': 'Luzhou', 'state': 'Sichuan', 'country': 'China', 'facility': 'The Affiliated Hospital of Southwest Medical University', 'geoPoint': {'lat': 28.8903, 'lon': 105.42575}}, {'city': 'Lhasa', 'state': 'Tibet', 'country': 'China', 'facility': "Tibet Autonomous Region People's Hospital", 'geoPoint': {'lat': 29.65, 'lon': 91.1}}, {'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': "Yan'an Hospital of Kunming City", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Hanzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital'}, {'city': 'Changsha', 'country': 'China', 'facility': 'Changsha Central Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'The Third Affiliated Hospital of CQMU', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'The Fifth Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai East Hospital Tongji University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Hongwei Zhou, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University First Hospital', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital Of Guizhou Medical University', 'class': 'OTHER'}, {'name': 'Hainan General Hospital', 'class': 'OTHER'}, {'name': 'LanZhou University', 'class': 'OTHER'}, {'name': 'Lianyungang Hospital Affiliated Bengbu Medical College', 'class': 'OTHER'}, {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, {'name': 'Jinan Central Hospital', 'class': 'OTHER'}, {'name': "Tibet Autonomous Region People's Hospital", 'class': 'OTHER'}, {'name': 'The Affiliated Hospital Of Southwest Medical University', 'class': 'OTHER'}, {'name': 'Anhui Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': "The First People's Hospital of Zunyi", 'class': 'OTHER'}, {'name': 'The Third Affiliated Hospital of Southern Medical University', 'class': 'OTHER_GOV'}, {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Zhuhai Center for Maternal and Child Health Care', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}, {'name': 'Qinghai Red Cross Hospital', 'class': 'OTHER'}, {'name': "Changzhi People's Hospital", 'class': 'OTHER'}, {'name': 'Shanghai East Hospital', 'class': 'OTHER'}, {'name': 'Fifth Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, {'name': 'Huizhou Municipal Central Hospital', 'class': 'OTHER'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, {'name': "Yuebei People's Hospital", 'class': 'OTHER'}, {'name': 'The Seventh Affiliated Hospital of Sun Yat-sen University', 'class': 'OTHER'}, {'name': 'Fujian Maternity and Child Health Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'The Fifth Affiliated Hospital of Southern Medical University', 'class': 'OTHER'}, {'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, {'name': 'Gansu Provincial Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Diagnostic Technician', 'investigatorFullName': 'Muxuan Chen', 'investigatorAffiliation': 'Zhujiang Hospital'}}}}