Oral Microbioma and Oral Malignant Disease

NCT ID: NCT05766150

Last Updated: 2023-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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Conditions

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Oral Cancer Oral Squamous Cell Carcinoma Premalignant Lesion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with no oral malignant disease

No interventions assigned to this group

Patients with oral premalignant disease

No interventions assigned to this group

Patients with oral malignant disease

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role collaborator

Academisch Ziekenhuis Maastricht

OTHER

Sponsor Role lead

Responsible Party

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Eliza Hagens

Drs. L.A.A. Vaassen & Dr. E.R.C. Hagens

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Deptartment of Oral and Maxillofacial Surgery, Maastricht UMC+

Maastricht, , Netherlands

Site Status RECRUITING

Department of Cranio- & Maxillofacial surgery, Radboud UMC

Nijmegen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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L.A.A. Vaassen

Role: CONTACT

+31 (0)43 3872010

E.R.C. Hagens

Role: CONTACT

+31 (0)43 3872479

Other Identifiers

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METC 2019-1251

Identifier Type: -

Identifier Source: org_study_id

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