HPV Infection and Genital Microecology of Childbearing-age Female in China: A Cohort and Multicenter Study

Uterine Cervical Neoplasms Clinical Trial

Official title:

HPV Infection and Genital Microecology of Childbearing-age Female in China: A Cohort and Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04694495
• Other study ID #: CALM2004
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Papillomavirus Infections
• Sexual Transmitted Disease
• Uterine Cervical Neoplasms

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