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

Sponsor

Zhujiang Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04694495

Collaborator

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

10,000

Enrollment

Locations

Anticipated Duration (Months)

238.1

Patients Per Site

9.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Papillomavirus Infections Uterine Cervical Neoplasms Sexual Transmitted Disease	Diagnostic Test: 16S rRNA gene sequencing of cervical secretions

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 12, 2020

Anticipated Primary Completion Date :

Dec 11, 2021

Anticipated Study Completion Date :

Dec 12, 2022

Arms and Interventions

Arm	Intervention/Treatment
volunteers from health examination center 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	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 Other Names: Microecology assessment of cervical secretions Genotyping of HPV and detection of sexually transmitted diseases pathogens Thinprep cytologic test of cervical exfoliated cells
volunteers from gynecology outpatient 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	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 Other Names: Microecology assessment of cervical secretions Genotyping of HPV and detection of sexually transmitted diseases pathogens Thinprep cytologic test of cervical exfoliated cells

Arm

Intervention/Treatment

volunteers from health examination center

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

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

Other Names:

Microecology assessment of cervical secretions

Genotyping of HPV and detection of sexually transmitted diseases pathogens

Thinprep cytologic test of cervical exfoliated cells

volunteers from gynecology outpatient

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

Diagnostic Test: 16S rRNA gene sequencing of cervical secretions

Other Names:

Microecology assessment of cervical secretions

Genotyping of HPV and detection of sexually transmitted diseases pathogens

Thinprep cytologic test of cervical exfoliated cells

Outcome Measures

Primary Outcome Measures

alteration of genital microecology from baseline at month 6 [basline and 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of USTC	Hefei	Anhui	China
2	The First Hospital of Lanzhou University	Lanzhou	Gansu	China
3	Chaozhou Central Hospital	Chaozhou	Guangdong	China
4	Dongguan People's Hospital	Dongguan	Guangdong	China
5	Guangdong Provincial Hospital of Intergrated Traditional Chinese and Western Medicine	Foshan	Guangdong	China
6	Zhujiang Hospital	Guangzhou	Guangdong	China	510000
7	Nanfang Hospital	Guangzhou	Guangdong	China
8	Taihe Branch of Nanfang Hospital	Guangzhou	Guangdong	China
9	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong	China
10	The Third Affiliated Hospital of Guangzhou University of Chinese Medicine	Guangzhou	Guangdong	China
11	The Third Affiliated Hospital of Southern Medical University	Guangzhou	Guangdong	China
12	Huizhou Municipal Central Hospital	Huizhou	Guangdong	China
13	Peking University Shenzhen Hospital	Shenzhen	Guangdong	China
14	Shenzhen Hospital of Guangzhou University of Chinese Medicine	Shenzhen	Guangdong	China
15	Shenzhen Luohu Hospital Group Luohu People's Hospital	Shenzhen	Guangdong	China
16	The Seventh Affiliated Hospital, Sun Yat-sen University	Shenzhen	Guangdong	China
17	The Third People's Hospital of Shenzhen	Shenzhen	Guangdong	China
18	Xiaolan People's Hospital of Zhongshan	Zhongshan	Guangdong	China
19	The First Affiliated Hospital, Sun Yat-Sen Univeristy	Guangzhou	Guangzhou	China
20	Zhuhai Women and Children's Hospital	Zhuhai	Guangzhou	China
21	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou	China
22	The First People's Hospital of Zunyi	Zunyi	Guizhou	China
23	Yue Bei People's Hospital	Shaoguan	Gunagdong	China
24	Hainan General Hospital	Haikou	Hainan	China
25	The Second Hospital of Hebei Medical University	Shijia Zhuang	Hebei	China
26	The First Hospital fo Qiqihar	Qiqihar	Hei Longjiang	China
27	The Second People's Hospital of Lianyungang	Lianyungang	Jiangsu	China
28	Jilin Central General Hospital	Jilin	Jilin	China
29	General Hospital of Ningxia Medical University	Yinchuan	Ningxia	China
30	Qinghai Red Cross Hospital	Xining	Qinghai	China
31	Jinan Central Hospital	Jinan	Shandong	China
32	Obstetrics&Gynecology Hospital of Fudan University	Shanghai	Shanghai	China
33	Changzhi People's Hospital	Changzhi	Shanxi	China
34	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi	China
35	The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan	China
36	Tibet Autonomous Region People's Hospital	Lasa	Tibet	China
37	Yan'an Hospital of Kunming City	Kunming	Yunnan	China
38	Sir Run Run Shaw Hospital	Hanzhou	Zhejiang	China
39	Changsha Central Hospital	Changsha		China
40	The Third Affiliated Hospital of CQMU	Chongqing		China
41	The Fifth Affiliated Hospital of Guangzhou Medical University	Guangzhou		China
42	Shanghai East Hospital Tongji University	Shanghai		China

Sponsors and Collaborators

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

Investigators

Principal Investigator: Hongwei Zhou, Doctor, Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Muxuan Chen, Diagnostic Technician, Zhujiang Hospital

ClinicalTrials.gov Identifier:

NCT04694495

Other Study ID Numbers:

CALM2004

First Posted:

Jan 5, 2021

Last Update Posted:

Aug 3, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Papillomavirus Infections

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Aug 3, 2021