Oral Cancer Clinical Trial
Official title:
Association Between Oral Microbioma With Developing of Oral (Pre)Malignant Disease.
This case-control study aims to investigate if oral microbioma is associated with developing oral (pre)malignant disease.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Deptartment of Oral and Maxillofacial Surgery, Maastricht UMC+ | Maastricht | |
Netherlands | Department of Cranio- & Maxillofacial surgery, Radboud UMC | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Academisch Ziekenhuis Maastricht | Radboud University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Through study completion, an average of 3 years | |
Secondary | 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. | Through study completion, an average of 3 years | |
Secondary | 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. | Through study completion, an average of 3 years |
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