Oral Microbioma and Oral Malignant Disease

Academisch Ziekenhuis Maastricht

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT05766150

METC 2019-1251

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 3 patient groups

Patients with no oral malignant disease

Patients with oral premalignant disease

Patients with oral malignant disease