Clinical trial · Observational
HPV Infection and Genital Microecology of Childbearing-age Female in China: A Cohort and Multicenter Study
NCT04694495CI-TRIAL-00091484completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study to access the relations between genital microecology, HPV infection and cervical intraepithelial neoplasia of childbearing-age female in China
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Papillomavirus Infections | — | UNRESOLVED | — |
| Sexual Transmitted Disease | — | UNRESOLVED | — |
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 16S rRNA gene sequencing of cervical secretions | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- volunteers from health examination center
- description
- 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
- interventionNames
- Diagnostic Test: 16S rRNA gene sequencing of cervical secretions
- label
- volunteers from gynecology outpatient
- description
- 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
- interventionNames
- Diagnostic Test: 16S rRNA gene sequencing of cervical secretions
Primary outcomes (1)
- measure
- alteration of genital microecology from baseline at month 6
- timeFrame
- basline and month 6
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDChen 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. PMID 41238551
- DERIVEDZhang 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. PMID 39468466