Clinical Trials Logo
  1. Home
  2. Oral Cancer
  3. NCT05766150
  4. Details
NCT05766150 Clinical Trial

Oral Microbioma and Oral Malignant Disease

Oral Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05766150
Other study ID # METC 2019-1251
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date December 2024

Study information
Verified date March 2023
Source Academisch Ziekenhuis Maastricht
Contact L.A.A. Vaassen
Phone +31 (0)43 3872010
Email lauretta.vaassen@mumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 2024
Est. primary completion date July 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Deptartment of Oral and Maxillofacial Surgery, Maastricht UMC+ Maastricht
Netherlands Department of Cranio- & Maxillofacial surgery, Radboud UMC Nijmegen

Sponsors (2)
Lead Sponsor Collaborator
Academisch Ziekenhuis Maastricht Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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. Through study completion, an average of 3 years
Secondary 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. Through study completion, an average of 3 years
See also
  Status Clinical Trial Phase
Recruiting NCT06031337 - Salivary Expression of SOX7 in Oral Squamous Cell Carcinoma: Diagnostic Accuracy Study
Completed NCT00158678 - IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC Phase 3
Completed NCT00933387 - A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma Phase 2
Enrolling by invitation NCT05030597 - Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma N/A
Completed NCT03682562 - Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions
Recruiting NCT03684707 - Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions Phase 4
Recruiting NCT06130332 - Neoadjuvant Tirellizumab Combined With Chemotherapy for Early Oral Squamous Cell Carcinoma(HNC-SYSU-004) Phase 2
Recruiting NCT04372914 - Prevention of Oral DNA Damage by Black Raspberries N/A
Active, not recruiting NCT03529422 - Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN Phase 2
Recruiting NCT03686020 - Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)
Not yet recruiting NCT06060288 - Diagnostic Accuracy of Mobile Phone Imaging Compared to Conventional Clinical Examination for Oral Cancer Screening
Withdrawn NCT00951470 - Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema N/A
Completed NCT00964977 - Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis. Phase 3
Completed NCT01418118 - Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery Phase 4
Active, not recruiting NCT00232960 - Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC N/A
Recruiting NCT05429099 - Mandibular Reconstruction Preplanning (ViPMR) Phase 2/Phase 3
Completed NCT04614896 - Use of Ultrasound for Measuring Size of Oral Tongue Cancers N/A
Recruiting NCT03685409 - Cancer Chemoprevention by Metformin Hydrochloride in Oral Potentially Malignant Lesions Phase 3
Completed NCT00402779 - Erlotinib Prevention of Oral Cancer (EPOC) Phase 3
Recruiting NCT05153733 - Improved Implant for Reconstruction Purposes After Mandibular Resection N/A