Oral Microbioma and Oral Malignant Disease

Sponsor

Academisch Ziekenhuis Maastricht (Other)

Overall Status

Recruiting

CT.gov ID

NCT05766150

Collaborator

Radboud University Medical Center (Other)

300

Enrollment

Locations

Anticipated Duration (Months)

150

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Oral Cancer Oral Squamous Cell Carcinoma Premalignant Lesion

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Patients with no oral malignant disease
Patients with oral premalignant disease
Patients with oral malignant disease

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Deptartment of Oral and Maxillofacial Surgery, Maastricht UMC+	Maastricht		Netherlands
2	Department of Cranio- & Maxillofacial surgery, Radboud UMC	Nijmegen		Netherlands

Sponsors and Collaborators

Academisch Ziekenhuis Maastricht
Radboud University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eliza Hagens, Drs. L.A.A. Vaassen & Dr. E.R.C. Hagens, Academisch Ziekenhuis Maastricht

ClinicalTrials.gov Identifier:

NCT05766150

Other Study ID Numbers:

METC 2019-1251

First Posted:

Mar 13, 2023

Last Update Posted:

Mar 13, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mouth Neoplasms

Squamous Cell Carcinoma of Head and Neck

Precancerous Conditions

Study Results

No Results Posted as of Mar 13, 2023