Oral CancerNCT05766150
Oral Microbioma and Oral Malignant Disease
An observational study of Oral Cancer and Oral Squamous Cell Carcinoma, run by Academisch Ziekenhuis Maastricht at 2 sites in Netherlands.
Trial summary
This case-control study aims to investigate if oral microbioma is associated with developing oral (pre)malignant disease. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Oral Cancer, Oral Squamous Cell Carcinoma, Premalignant Lesion
- How many people
- 300 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Dec 2021to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Persons visiting oral and maxillofacial surgery department in Maastricht UMC or Radboud UMC who meet the inclusion criteria can be included.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Deptartment of Oral and Maxillofacial Surgery, Maastricht UMC+
Maastricht
- Recruiting
Department of Cranio- & Maxillofacial surgery, Radboud UMC
Nijmegen
About this study
Official title: 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.
- Medical subject headings
- Mouth Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with no oral malignant disease | Not described | |
| Patients with oral premalignant disease | Not described | |
| Patients with oral malignant disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Prevalence of different oral pathogens will be displayed for patients of both age groups.
Measured: Through study completion, an average of 3 years
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.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Dec 2021
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Ziekenhuis Maastricht
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Principal investigator, Eliza Hagens, Academisch Ziekenhuis Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766150
- Sponsor's protocol ID
- METC 2019-1251
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Oral Microbioma With Developing of Oral (Pre)Malignant Disease.
- ClinicalTrials.gov ID
- NCT05766150
- Acronym / sponsor ID
- METC 2019-1251
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Academisch Ziekenhuis MaastrichtUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This case-control study aims to investigate if oral microbioma is associated with developing oral (pre)malignant disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with no oral malignant disease | – | – |
| Patients with oral premalignant disease | – | – |
| Patients with oral malignant disease | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Persons visiting oral and maxillofacial surgery department in Maastricht UMC or Radboud UMC who meet the inclusion criteria can be included.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
To desribe the difference in oral microbioma and stage of disease upon presentation.
Time frame: Through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cancer and Oral Squamous Cell Carcinoma, run by Academisch Ziekenhuis Maastricht at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact L.A.A. Vaassen (+31 (0)43 3872010, lauretta.vaassen@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between oral microbioma and (pre)malignant disease. (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.