Papillomavirus InfectionsNCT04694495
HPV Infection and Genital Microecology of Childbearing-age Female in China: A Cohort and Multicenter Study
An observational study of Papillomavirus Infections and Uterine Cervical Neoplasms, run by Zhujiang Hospital at 42 sites in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Infections, Uterine Cervical Neoplasms, Sexual Transmitted Disease
- What is being tested?
- 16S rRNA gene sequencing of cervical secretions
- How many people
- 7,500 participants
- Where
- 42 sitesChina
- Study dates
- 12 Nov 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Volunteers will be recruited from both outpatient department of gynecology and health examination center in each research center
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
China42 sites
Changsha Central Hospital
Changsha
Changzhi People's Hospital
Changzhi, Shanxi
Chaozhou Central Hospital
Chaozhou, Guangdong
The Third Affiliated Hospital of CQMU
Chongqing
Dongguan People's Hospital
Dongguan, Guangdong
Guangdong Provincial Hospital of Intergrated Traditional Chinese and Western Medicine
Foshan, Guangdong
Zhujiang Hospital
Guangzhou, Guangdong, 510000
Nanfang Hospital
Guangzhou, Guangdong
Taihe Branch of Nanfang Hospital
Guangzhou, Guangdong
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong
The Third Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong
The First Affiliated Hospital, Sun Yat-Sen Univeristy
Guangzhou, Guangzhou
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
Hainan General Hospital
Haikou, Hainan
Sir Run Run Shaw Hospital
Hanzhou, Zhejiang
The First Affiliated Hospital of USTC
Hefei, Anhui
Huizhou Municipal Central Hospital
Huizhou, Guangdong
Jilin Central General Hospital
Jilin City, Jilin
Jinan Central Hospital
Jinan, Shandong
Yan'an Hospital of Kunming City
Kunming, Yunnan
The First Hospital of Lanzhou University
Lanzhou, Gansu
Tibet Autonomous Region People's Hospital
Lhasa, Tibet
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan
The First Hospital fo Qiqihar
Qiqihar, Hei Longjiang
Obstetrics&Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality
Shanghai East Hospital Tongji University
Shanghai
Yue Bei People's Hospital
Shaoguan, Gunagdong
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Shenzhen Hospital of Guangzhou University of Chinese Medicine
Shenzhen, Guangdong
Shenzhen Luohu Hospital Group Luohu People's Hospital
Shenzhen, Guangdong
The Seventh Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Qinghai Red Cross Hospital
Xining, Qinghai
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Xiaolan People's Hospital of Zhongshan
Zhongshan, Guangdong
Zhuhai Women and Children's Hospital
Zhuhai, Guangzhou
The First People's Hospital of Zunyi
Zunyi, Guizhou
About this study
The purpose of this study to access the relations between genital microecology, HPV infection and cervical intraepithelial neoplasia of childbearing-age female in China
Read the 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.
- Being tested
- 16S rRNA gene sequencing of cervical secretions
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16S rRNA gene sequencing of cervical secretionsDiagnostic test
Also called Microecology assessment of cervical secretions, Genotyping of HPV and detection of sexually transmitted diseases pathogens, Thinprep cytologic test of cervical exfoliated cells
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: 16S rRNA gene sequencing of cervical secretions | |
| 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 Receives: Diagnostic Test: 16S rRNA gene sequencing of cervical secretions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: basline and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start12 Nov 2020
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Muxuan Chen, Zhujiang Hospital
- Investigators
- Hongwei Zhou, Doctor, Principal investigator, Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694495
- Sponsor's protocol ID
- CALM2004
- Status last verified
- Jun 2025
- First submitted
- 3 Jan 2021
- Last updated
- 27 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41238551Zhang 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.
PubMed 39468466
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Infection and Genital Microecology of Childbearing-age Female in China: A Cohort and Multicenter Study
- ClinicalTrials.gov ID
- NCT04694495
- Acronym / sponsor ID
- CALM2004
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,500 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- 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
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| volunteers from health examination center | – | Diagnostic Test: 16S rRNA gene sequencing of cervical secretionsvolunteers(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 |
| volunteers from gynecology outpatient | – | Diagnostic Test: 16S rRNA gene sequencing of cervical secretionsvolunteers(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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Volunteers will be recruited from both outpatient department of gynecology and health examination center in each research center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 16S rRNA gene sequencing of cervical secretionsAlso: Microecology assessment of cervical secretions, Genotyping of HPV and detection of sexually transmitted diseases pathogens, Thinprep cytologic test of cervical exfoliated cells1. 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 | Diagnostic test | volunteers from gynecology outpatient, volunteers from health examination center |
Primary outcome
alteration of genital microecology from baseline at month 6
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Derived from this study: PubMed 41238551Chen 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.
- Derived from this study: PubMed 39468466Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongwei Zhou, Doctor principal investigator
Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillomavirus Infections and Uterine Cervical Neoplasms, run by Zhujiang Hospital at 42 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alteration of genital microecology from baseline at month 6 (time frame: basline and month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04694495, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.