Papillomavirus Infections, Sexual Transmitted Disease, Uterine Cervical Neoplasms
Conditions
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
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.
Interventions
DIAGNOSTIC_TEST16S rRNA gene sequencing of cervical secretions
1. 16S rRNA gene sequencing of vaginal secretions: using NGS technology to assess the microbiota of the vaginal secretions 2. Microecology assessment of vaginal secretions: morphology test, functional assessment and Nugent score assessment of the vaginal secretions are included. 3. Genotyping of HPV and detection of sexually transmitted diseases pathogens based on the cervical exfoliated cells 4. Thinprep cytologic test of cervical exfoliated cells: to evaluate the grade of cervical intraepithelial neoplasia
Sponsors
Peking University First Hospital
The Affiliated Hospital Of Guizhou Medical University
Hainan General Hospital
LanZhou University
Lianyungang Hospital Affiliated Bengbu Medical College
General Hospital of Ningxia Medical University
Jinan Central Hospital
Tibet Autonomous Region People's Hospital
The Affiliated Hospital Of Southwest Medical University
Anhui Provincial Hospital
The First People's Hospital of Zunyi
The Third Affiliated Hospital of Southern Medical University
First Affiliated Hospital, Sun Yat-Sen University
Zhuhai Center for Maternal and Child Health Care
First Affiliated Hospital of Guangxi Medical University
Qinghai Red Cross Hospital
Changzhi People's Hospital
Shanghai East Hospital
Fifth Affiliated Hospital of Guangzhou Medical University
Huizhou Municipal Central Hospital
Nanfang Hospital, Southern Medical University
Yuebei People's Hospital
The Seventh Affiliated Hospital of Sun Yat-sen University
Fujian Maternity and Child Health Hospital
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Henan Provincial People's Hospital
The Fifth Affiliated Hospital of Southern Medical University
Shandong Provincial Hospital
First Hospital of China Medical University
Gansu Provincial Hospital
Zhujiang Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed