Association Between Oral Microbioma With Developing of Oral (Pre)Malignant Disease.

Academisch Ziekenhuis Maastricht2 sites in 1 country300 target enrollmentDecember 1, 2021

ConditionsOral Cancer Oral Squamous Cell Carcinoma Premalignant Lesion

Overview

Phase: N/A
Intervention: Not specified
Conditions: Oral Cancer
Sponsor: Academisch Ziekenhuis Maastricht
Enrollment: 300
Locations: 2
Primary Endpoint: Association between oral microbioma and (pre)malignant disease.
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This case-control study aims to investigate if oral microbioma is associated with developing oral (pre)malignant disease.

Registry

clinicaltrials.gov

Start Date

December 1, 2021

End Date

December 2024

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Academisch Ziekenhuis Maastricht

Responsible Party

Principal Investigator

Eliza Hagens

Drs. L.A.A. Vaassen & Dr. E.R.C. Hagens

Academisch Ziekenhuis Maastricht

Eligibility Criteria

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

Outcomes

Primary Outcomes

Association between oral microbioma and (pre)malignant disease.

Time Frame: Through study completion, an average of 3 years

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

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.(Through study completion, an average of 3 years)
To desribe the difference in oral microbioma and stage of disease upon presentation.(Through study completion, an average of 3 years)