Epigenetic Biomarkers in the Saliva for the Diagnosis of Squamous Cells Carcinoma of the Oral Cavity
EPSACO
1 other identifier
interventional
60
1 country
1
Brief Summary
Head and neck squamous cell carcinoma (HNSCC) are malignant tumors originating from the epithelial mucosa of the upper aerodigestive tract. The oral cavity is the most frequent location of HNSCC (oral squamous cell carcinoma: OSCC). Tobacco use and alcohol consumption are the greatest risk factors. The Hauts de France region has one of the highest incidence rates of OSCC. The overall survival of patients with OSCC remains low, with a 5-year overall survival rate of around 60%. In addition to the oncological prognosis, OSCCs and their treatment have a significant impact on the quality of life of patients. An early diagnosis of OSCC is recommended, but it remains difficult. It can be for example challenging to diagnose OSCC in a context of oral premalignant lesions. Identifying objective biomarkers of malignancy would be an advantage and would allow better progress in the field of precision medicine and surgery for these tumors. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 3, 2022
CompletedFirst Submitted
Initial submission to the registry
March 17, 2023
CompletedFirst Posted
Study publicly available on registry
March 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedMarch 30, 2023
March 1, 2023
1.1 years
March 17, 2023
March 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of methylated gene in both groups : control and OSCC patients
one year
Secondary Outcomes (2)
Percentage of methylated gene in OSCC patients before surgery
one year
Percentage of methylated gene in OSCC patients after surgery
one year
Study Arms (2)
OSCC patients
EXPERIMENTALcontrols
ACTIVE COMPARATORInterventions
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
You may qualify if:
- Patient group:
- 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
You may not qualify if:
- Patients with other types of cancer
- Patients under the age of 18
- Pregnant or breastfeeding women
- Patients under guardianship, curators, legal protection or deprived of liberty
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Amiens University Hospital
Amiens, Picardie, 80054, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2023
First Posted
March 30, 2023
Study Start
March 3, 2022
Primary Completion
April 1, 2023
Study Completion
October 1, 2023
Last Updated
March 30, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share