Oral Microbioma and Oral Malignant Disease
Association Between Oral Microbioma With Developing of Oral (Pre)Malignant Disease.
1 other identifier
observational
300
1 country
2
Brief Summary
This case-control study aims to investigate if oral microbioma is associated with developing oral (pre)malignant disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 22, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMarch 13, 2023
March 1, 2023
2.6 years
February 22, 2023
March 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
To desribe the difference in oral microbioma and stage of disease upon presentation.
Through study completion, an average of 3 years
Study Arms (3)
Patients with no oral malignant disease
Patients with oral premalignant disease
Patients with oral malignant disease
Eligibility Criteria
Persons visiting oral and maxillofacial surgery department in Maastricht UMC or Radboud UMC who meet the inclusion criteria can be included.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Deptartment of Oral and Maxillofacial Surgery, Maastricht UMC+
Maastricht, Netherlands
Department of Cranio- & Maxillofacial surgery, Radboud UMC
Nijmegen, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Drs. L.A.A. Vaassen & Dr. E.R.C. Hagens
Study Record Dates
First Submitted
February 22, 2023
First Posted
March 13, 2023
Study Start
December 1, 2021
Primary Completion
July 1, 2024
Study Completion
December 1, 2024
Last Updated
March 13, 2023
Record last verified: 2023-03