Clinical trial · Observational
Research About Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection
Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection：a Multi-center Cohort Study in China
- 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)
Clinically, patients with persistent HR-HPV infection for more than 18 months or HR-HPV infection with CIN2 + need regular colposcopic biopsy to assess the outcome and progression of the disease. A total of 1000 participants with persistent HR-HPV infection (100 cases/center) were recruited from multiple centers, and HPV integration status and vaginal flora diversity were sequenced at baseline, 6th month, 12th month and 24th month, respectively, through prospective cohort studies. And to evaluate the influence of HPV integration status and flora changes on the prognosis of women with persistent HR-HPV infection.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV Infection | — | UNRESOLVED | — |
| HSIL, High-Grade Squamous Intraepithelial Lesions | High Grade Squamous Intraepithelial Neoplasia | ALIAS | 0.85 |
| LSIL, Low-Grade Squamous Intraepithelial Lesions | Low Grade Squamous Intraepithelial Neoplasia | ALIAS | 0.85 |
| Virus Integration | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Follow up | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women with persistent HR-HPV infection
- description
- In the enrollment, women with persistent HR-HPV infection for more than 18 months will be included in this study. All participants will be followed up at 6th month, 12th month, 18th month and 24th month after baseline of recruitment.
- interventionNames
- Other: Follow up
Primary outcomes (20)
- measure
- Cervical histopathology testing at baseline
- timeFrame
- Baseline
- description
- Cervical histopathology was performed at baseline for all participants.
- measure
- Cervical histopathology testing at 6-month follow-up
- timeFrame
- 6-month follow-up
- description
- Cervical histopathology was performed at 6-month follow-up for cervical HR-HPV infection or cytology abnormalities women
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Non pregnant people with sexual history； * Persistent infection of the same type of HR-HPV for more than 18 months or HR-HPV infection with CIN2 +; * No history of previous surgery at the cervical site. * Asexual life, no vaginal medication or flushing before 72 hours of sampling. Exclusion Criteria: * Within 8 weeks after pregnancy or postpartum. * Patients with history of genital tract tumor. * History of HPV vaccination. * Previous history of hysterectomy, cervical surgery, pelvic radiotherapy Historical. * In recent one month, she has received genital tract infection, HPV or other STDs treatment related to the infection of mycoplasma. * Use antibiotics or vaginal microecological improvement products in recent 1 month.
References
Publications (0)
Data not yet available