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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04694495
Other study ID # CALM2004
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 12, 2020
Est. completion date December 12, 2022

Study information

Verified date August 2021
Source Zhujiang Hospital
Contact Muxuan Chen
Phone +8613580561916
Email muxuanchen@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study to access the relations between genital microecology, HPV infection and cervical intraepithelial neoplasia of childbearing-age female in China


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date December 12, 2022
Est. primary completion date December 11, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Female of childbearing age conducting thinprep cytologic test - Having an experience of sexual intercourse - Not during the menstrual period - No sexual intercourse or vaginal medication or vaginal flushing in 3 days before sampling Exclusion Criteria: - Within 8 weeks of pregnancy or postpartum - Having had tumors in reproductive tract - Having had HPV bivalent, tetravalent or nine-valent vaccination - Having received treatment for anti- HPV or other STDs pathogens infection - Having had hysterectomy, cervical surgery and pelvic radiotherapy - Having used broad-spectrum antibiotics, probiotics or vaginal suppositories in reproductive tract within 1 month

Study Design


Intervention

Diagnostic Test:
16S rRNA gene sequencing of cervical secretions
16S rRNA gene sequencing of vaginal secretions: using NGS technology to assess the microbiota of the vaginal secretions Microecology assessment of vaginal secretions: morphology test, functional assessment and Nugent score assessment of the vaginal secretions are included. Genotyping of HPV and detection of sexually transmitted diseases pathogens based on the cervical exfoliated cells Thinprep cytologic test of cervical exfoliated cells: to evaluate the grade of cervical intraepithelial neoplasia

Locations

Country Name City State
China Changsha Central Hospital Changsha
China Changzhi People's Hospital Changzhi Shanxi
China Chaozhou Central Hospital Chaozhou Guangdong
China The Third Affiliated Hospital of CQMU Chongqing
China Dongguan People's Hospital Dongguan Guangdong
China Guangdong Provincial Hospital of Intergrated Traditional Chinese and Western Medicine Foshan Guangdong
China Nanfang Hospital Guangzhou Guangdong
China Taihe Branch of Nanfang Hospital Guangzhou Guangdong
China The Fifth Affiliated Hospital of Guangzhou Medical University Guangzhou
China The First Affiliated Hospital of Jinan University Guangzhou Guangdong
China The First Affiliated Hospital, Sun Yat-Sen Univeristy Guangzhou Guangzhou
China The Third Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou Guangdong
China The Third Affiliated Hospital of Southern Medical University Guangzhou Guangdong
China Zhujiang Hospital Guangzhou Guangdong
China The Affiliated Hospital of Guizhou Medical University Guiyang Guizhou
China Hainan General Hospital Haikou Hainan
China Sir Run Run Shaw Hospital Hanzhou Zhejiang
China The First Affiliated Hospital of USTC Hefei Anhui
China Huizhou Municipal Central Hospital Huizhou Guangdong
China Jilin Central General Hospital Jilin Jilin
China Jinan Central Hospital Jinan Shandong
China Yan'an Hospital of Kunming City Kunming Yunnan
China The First Hospital of Lanzhou University Lanzhou Gansu
China Tibet Autonomous Region People's Hospital Lasa Tibet
China The Second People's Hospital of Lianyungang Lianyungang Jiangsu
China The Affiliated Hospital of Southwest Medical University Luzhou Sichuan
China The First Hospital fo Qiqihar Qiqihar Hei Longjiang
China Obstetrics&Gynecology Hospital of Fudan University Shanghai Shanghai
China Shanghai East Hospital Tongji University Shanghai
China Yue Bei People's Hospital Shaoguan Gunagdong
China Peking University Shenzhen Hospital Shenzhen Guangdong
China Shenzhen Hospital of Guangzhou University of Chinese Medicine Shenzhen Guangdong
China Shenzhen Luohu Hospital Group Luohu People's Hospital Shenzhen Guangdong
China The Seventh Affiliated Hospital, Sun Yat-sen University Shenzhen Guangdong
China The Third People's Hospital of Shenzhen Shenzhen Guangdong
China The Second Hospital of Hebei Medical University Shijia Zhuang Hebei
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi
China Qinghai Red Cross Hospital Xining Qinghai
China General Hospital of Ningxia Medical University Yinchuan Ningxia
China Xiaolan People's Hospital of Zhongshan Zhongshan Guangdong
China Zhuhai Women and Children's Hospital Zhuhai Guangzhou
China The First People's Hospital of Zunyi Zunyi Guizhou

Sponsors (45)

Lead Sponsor Collaborator
Zhujiang Hospital Changsha Central Hospital, Changzhi People's Hospital, Chaozhou Central Hospital, Dongguan People's Hospital, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Jinan University, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital, Sun Yat-Sen University, General Hospital of Ningxia Medical University, Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine, Hainan People's Hospital, Huizhou Municipal Central Hospital, Jilin Central General Hospital, Jinan Central Hospital, LanZhou University, Lianyungang Hospital Affiliated Bengbu Medical College, Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region, Nanfang Hospital of Southern Medical University, Obstetrics & Gynecology Hospital of Fudan University, Peking University Hospital, Peking University Shenzhen Hospital, Qinghai Red Cross Hospital, Shanghai East Hospital Tongji University, Shenzhen Hospital of Guangzhou University of Chinese Medicine, Shenzhen Luohu Hospital Group Luohu People's Hospital, Shenzhen Third People's Hospital, Sir Run Run Shaw Hospital, Taihe Branch of Nanfang Hospital, The Affiliated Hospital Of Guizhou Medical University, The Affiliated Hospital Of Southwest Medical University, The Fifth Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of University of Science and Technology of China, The First Hospital fo Qiqihar, The Second Hospital of Hebei Medical University, The Seventh Affiliated Hospital of Sun Yat-sen University, The Third Affiliated Hospital of CQMU, The Third Affiliated Hospital of Guangzhou University of Chinese Medicine, The Third Affiliated Hospital of Southern Medical University, Tibet Autonomous Region People's Hospital, Xiaolan People's Hospital of Zhongshan, Yan'an Hospital of Kunming City, Yuebei People's Hospital, Zhuhai Center for Maternal and Child Health Care, Zunyi First People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary alteration of genital microecology from baseline at month 6 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. basline and month 6
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