Oral Microbioma and Oral Malignant Disease

March 10, 2023 updated by: Eliza Hagens, Academisch Ziekenhuis Maastricht

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Recruiting
        • Deptartment of Oral and Maxillofacial Surgery, Maastricht UMC+
      • Nijmegen, Netherlands
        • Recruiting
        • Department of Cranio- & Maxillofacial surgery, Radboud UMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Persons visiting oral and maxillofacial surgery department in Maastricht UMC or Radboud UMC who meet the inclusion criteria can be included.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with no oral malignant disease
Patients with oral premalignant disease
Patients with oral malignant disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between oral microbioma and (pre)malignant disease.
Time Frame: 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.
Through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Through study completion, an average of 3 years
Prevalence of different oral pathogens will be displayed for patients of both age groups.
Through study completion, an average of 3 years
To desribe the difference in oral microbioma and stage of disease upon presentation.
Time Frame: Through study completion, an average of 3 years
Prevalence of different oral pathogens will be displayed for patientgroups with different tumor stages.
Through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Ziekenhuis Maastricht

Collaborators

Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

March 10, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC 2019-1251

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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