Oral Microbioma and Oral Malignant Disease

Oral Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766150
• Other study ID #: METC 2019-1251
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Academisch Ziekenhuis Maastricht
• Contact: L.A.A. Vaassen
• Phone: +31 (0)43 3872010
• Email: lauretta.vaassen[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• 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

Related Conditions & MeSH terms

• Mouth Neoplasms
• Oral Cancer
• Oral Squamous Cell Carcinoma
• Precancerous Conditions
• Premalignant Lesion
• Squamous Cell Carcinoma of Head and Neck

Locations

Country	Name	City	State
Netherlands	Deptartment of Oral and Maxillofacial Surgery, Maastricht UMC+	Maastricht
Netherlands	Department of Cranio- & Maxillofacial surgery, Radboud UMC	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Ziekenhuis Maastricht	Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

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