Oral Microbioma and Oral Malignant Disease

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05766150

Enrollment

300

Registered

2023-03-13

Start date

2021-12-01

Completion date

2024-12-31

Last updated

2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Cancer, Oral Squamous Cell Carcinoma, Premalignant Lesion

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Netherlands

Contacts

Primary ContactL.A.A. Vaassen

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

Backup ContactE.R.C. Hagens

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

Outcome results