Epigenetic Biomarkers in the Saliva for the Diagnosis of Squamous Cells Carcinoma of the Oral Cavity

Trial Title: Epigenetic Biomarkers in the Saliva for the Diagnosis of Squamous Cells Carcinoma of the Oral Cavity

NCT ID: NCT05791149

Condition: Oral Squamous Cell Carcinoma
Maxillo-facial Surgery
Biomarkers
Saliva
DNA Methylation
Epigenetics

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck

Conditions: Keywords:
Oral Squamous Cell Carcinoma
Maxillo-facial surgery
Biomarkers
Saliva
DNA Methylation
epigenetics

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Basic Science

Masking: Single (Participant)

Intervention:

Intervention type: Diagnostic Test
Intervention name: saliva tube
Description: 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
Arm group label: OSCC patients
Arm group label: controls

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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 Exclusion Criteria: - 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Amiens University Hospital

Address:
City: Amiens
Zip: 80054
Country: France

Status: Recruiting

Contact:
Last name: Zuzana Saidak, MD

Phone: 03 22 08 70 84
Email: saidak.zuzana@chu-amiens.fr

Investigator:
Last name: Stéphanie Dakpé, Pr
Email: Sub-Investigator

Investigator:
Last name: Sylvie Testelin, Pr
Email: Sub-Investigator

Investigator:
Last name: Christophe Attencourt, MD
Email: Sub-Investigator

Investigator:
Last name: Antoine Galmiche
Email: Sub-Investigator

Start date: March 3, 2022

Completion date: October 2023

Lead sponsor:
Agency: Centre Hospitalier Universitaire, Amiens
Agency class: Other

Source: Centre Hospitalier Universitaire, Amiens

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05791149