Oral Microbioma and Oral Malignant Disease

Recruiting

• Conditions: Oral Cancer; Oral Squamous Cell Carcinoma; Premalignant Lesion

• Registration Number: NCT05766150
• Lead Sponsor: Academisch Ziekenhuis Maastricht

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2023-02-22
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-10
• Last Update Submitted: 2023-03-10
• Study First Posted: 2023-03-13
• Last Update Posted: 2023-03-13
• Primary Completion: 2024-07
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association between oral microbioma and (pre)malignant disease.	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 Outcome Measures

Name	Time	Method
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	Prevalence of different oral pathogens will be displayed for patients of both age groups.
To desribe the difference in oral microbioma and stage of disease upon presentation.	Through study completion, an average of 3 years	Prevalence of different oral pathogens will be displayed for patientgroups with different tumor stages.

Trial Locations

Locations (2)

Deptartment of Oral and Maxillofacial Surgery, Maastricht UMC+; 🇳🇱 Maastricht, Netherlands

Department of Cranio- & Maxillofacial surgery, Radboud UMC; 🇳🇱 Nijmegen, Netherlands