Clinical trial · Observational
Oral Microbioma and Oral Malignant Disease
Association Between Oral Microbioma With Developing of Oral (Pre)Malignant Disease.
NCT05766150CI-TRIAL-00064629unknownClinicalTrials.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)
This case-control study aims to investigate if oral microbioma is associated with developing oral (pre)malignant disease.
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 |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oral Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
| Premalignant Lesion | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Patients with no oral malignant disease
- label
- Patients with oral premalignant disease
- label
- Patients with oral malignant disease
Primary outcomes (1)
- measure
- Association between oral microbioma and (pre)malignant disease.
- timeFrame
- Through study completion, an average of 3 years
- description
- Prevalence of clusters of different oral pathogens will be displayed for patients with malignant disease, premalignant disease and no oral malignancy. Taxonomic representation of statistically and biologically consistent differences between patients with malignant disease, premalignant disease and no oral malignant disease will be displayed.
Secondary outcomes (2)
- measure
- To describe the difference in oral microbioma between young (>40 years) patients with oral SCC and older (>40 years) patients with oral squamous cell carcinoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥18 years in case of oral malignancy or premalignant disease, ≥40 years in case of no malignant disease * Patients are (partially) dentate (≥20 teeth) * Patients who have given written informed consent to participate in this study Exclusion Criteria: * Patients with a history of radiotherapy in head and neck region * Patients with a history of chemotherapy, immunotherapy or immunomodulating drugs * Patients with a previous malginancy in head and neck region * Edentulous patients (with or without implants) * Patients with removable (partial) dentures
References
Publications (0)
Data not yet available
No reference posted for this study.