Clinical trial · Observational
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Assessing Personalized Vaginal Microbiome Contributions to HPV-driven Pre-malignant and Malignant Cervical Cancer
- 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)
In this study, the investigators will prospectively collect, analyze and integrate information regarding vaginal microbiome composition and HPV presence in women with cervical pathologies (high-grade CIN and CC) and controls, to construct a large dataset from patients with pre-cancerous cervical lesions and healthy women, to evaluate the personalized contribution of the vaginal microbiome to the CIN-CC sequence.
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 |
|---|---|---|---|
| Cancer Cervix Uterus | — | UNRESOLVED | — |
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Human Papilloma Virus | — | UNRESOLVED | — |
| Vaginal Flora Imbalance | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Controls
- description
- Healthy women without HPV in their cervical and vaginal sample
- label
- Women with HPV
- description
- Women with HPV, with or without cervical intraepithelial neoplasia or carcinoma
Primary outcomes (1)
- measure
- Characterization of the microbiome using molecular methods.
- timeFrame
- 1 year
- description
- Comparison of microbiome profiles between those with HPV compared to controls without HPV.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age 25-70 * Attended the clinic for a Pap smear or colposcopy Exclusion Criteria: * Patient does not approve sample collection * Usage of antibiotics in the month prior to clinic visit * Usage of any vaginal preparation or medication in the week prior to sample collection (anti-fungal, spermicides, lubricant etc.) * Menstruation * Pregnancy
References
Publications (0)
Data not yet available