Epigenetic Biomarkers in the Saliva for the Diagnosis of Squamous Cells Carcinoma of the Oral Cavity
NCT ID: NCT05791149
Last Updated: 2023-03-30
Study Results
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-03-03
2023-10-31
Brief Summary
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The investigators propose to establish the diagnostic use of an optimized DNA methylation profile detected in the saliva of OSCC patients by comparing these epigenetic marks before and after tumor resection.
The investigators will construct a consolidated signature of 4 genes whose DNA is subject to methylation and gene expression is restricted to cancer cells, by crossing TCGA analysis with single-cell analysis (single-cell RNA sequencing).
The investigators propose to analyse DNA methylation of the corresponding genes in the saliva of n=30 OSCC patients recruited for primary surgical resection in the Department of Maxillofacial Surgery vs controls. In addition, the investigators will examine the methylation profiles before / after complete excisional surgery of OSCC. This pilot study will aim to validate the analysis of DNA methylation markers in saliva of OSCC, with the aim of improving the diagnostic precision of OSCC and, secondly, to compare these markers before and after treatment by primary surgery.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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OSCC patients
saliva tube
1 tube of saliva (\~2 ml) will be collected from all patients enrolled in the study. For operated OSCC patients a second tube will be collected during the routine hospital visit 4 weeks after surgery
controls
saliva tube
1 tube of saliva (\~2 ml) will be collected from all patients enrolled in the study. For operated OSCC patients a second tube will be collected during the routine hospital visit 4 weeks after surgery
Interventions
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saliva tube
1 tube of saliva (\~2 ml) will be collected from all patients enrolled in the study. For operated OSCC patients a second tube will be collected during the routine hospital visit 4 weeks after surgery
Eligibility Criteria
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Inclusion Criteria
* Patients from the maxillofacial surgery department treated for a histologically confirmed squamous cell carcinoma of the oral cavity
* Patients whose first-line treatment decision at the multidisciplinary meeting in the service of Maxillofacial Surgery is surgery
* Patients who have not yet been treated surgically or by neoadjuvant treatment
* Patients over 18 years old
* Patients who have provided free and informed consent in writing
* Patients benefiting from a social security scheme
Control group:
* Patients in the maxillofacial surgery department not covered for head and neck cancer
* Patients over 18 years old
* Patients who have provided free and informed consent in writing
* Patients benefiting from a social security scheme
* Control group homogeneous with the patient group according to age, sex, tobacco and alcohol consumption
Exclusion Criteria
* Patients under the age of 18
* Pregnant or breastfeeding women
* Patients under guardianship, curators, legal protection or deprived of liberty
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire, Amiens
OTHER
Responsible Party
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Locations
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Amiens University Hospital
Amiens, Picardie, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PI2022_843_0042
Identifier Type: -
Identifier Source: org_study_id
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