Oral Microbioma and Oral Malignant Disease

Academisch Ziekenhuis Maastricht300 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Oral Cancer Oral Squamous Cell Carcinoma Premalignant Lesion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (2)

Deptartment of Oral and Maxillofacial Surgery, Maastricht UMC+

Maastricht, Netherlands

RECRUITING

Department of Cranio- & Maxillofacial surgery, Radboud UMC

Nijmegen, Netherlands

RECRUITING

Outcomes

Primary Outcomes

Association between oral microbioma and (pre)malignant disease.

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.

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

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.

Prevalence of different oral pathogens will be displayed for patients of both age groups.

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

To desribe the difference in oral microbioma and stage of disease upon presentation.

Prevalence of different oral pathogens will be displayed for patientgroups with different tumor stages.

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

Central Contacts

L.A.A. Vaassen

CONTACT

+31 (0)43 3872010 lauretta.vaassen@mumc.nl

E.R.C. Hagens

CONTACT

+31 (0)43 3872479 eliza.hagens@mumc.nl

Data from ClinicalTrials.gov

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