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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05791149

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Squamous Cell Carcinoma Maxillo-facial Surgery Biomarkers Saliva DNA Methylation Epigenetics	Diagnostic Test: saliva tube	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Mar 3, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OSCC patients	Diagnostic Test: 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
Active Comparator: controls	Diagnostic Test: 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

Arm

Intervention/Treatment

Experimental: OSCC patients

Diagnostic Test: 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

Active Comparator: controls

Diagnostic Test: 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

Outcome Measures

Primary Outcome Measures

Percentage of methylated gene in both groups : control and OSCC patients [one year]

Secondary Outcome Measures

Percentage of methylated gene in OSCC patients before surgery [one year]
Percentage of methylated gene in OSCC patients after surgery [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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