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

Primary Purpose

Oral Squamous Cell Carcinoma, Maxillo-facial Surgery, Biomarkers

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
saliva tube
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Oral Squamous Cell Carcinoma focused on measuring Oral Squamous Cell Carcinoma, Maxillo-facial surgery, Biomarkers, Saliva, DNA Methylation, epigenetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

  • Amiens University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OSCC patients

controls

Arm Description

Outcomes

Primary Outcome Measures

Percentage of methylated gene in both groups : control and OSCC patients

Secondary Outcome Measures

Percentage of methylated gene in OSCC patients before surgery
Percentage of methylated gene in OSCC patients after surgery

Full Information

First Posted
March 17, 2023
Last Updated
March 17, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT05791149
Brief Title
Epigenetic Biomarkers in the Saliva for the Diagnosis of Squamous Cells Carcinoma of the Oral Cavity
Acronym
EPSACO
Official Title
Epigenetic Biomarkers in the Saliva for the Diagnosis of Squamous Cells Carcinoma of the Oral Cavity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Squamous Cell Carcinoma, Maxillo-facial Surgery, Biomarkers, Saliva, DNA Methylation, Epigenetics
Keywords
Oral Squamous Cell Carcinoma, Maxillo-facial surgery, Biomarkers, Saliva, DNA Methylation, epigenetics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OSCC patients
Arm Type
Experimental
Arm Title
controls
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
saliva tube
Intervention 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
Primary Outcome Measure Information:
Title
Percentage of methylated gene in both groups : control and OSCC patients
Time Frame
one year
Secondary Outcome Measure Information:
Title
Percentage of methylated gene in OSCC patients before surgery
Time Frame
one year
Title
Percentage of methylated gene in OSCC patients after surgery
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zuzana SAIDAK, PhD
Phone
03 22 08 70 84
Email
saidak.zuzana@chu-amiens.fr
Facility Information:
Facility Name
Amiens University Hospital
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zuzana Saidak, MD
Phone
03 22 08 70 84
Email
saidak.zuzana@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Stéphanie Dakpé, Pr
First Name & Middle Initial & Last Name & Degree
Sylvie Testelin, Pr
First Name & Middle Initial & Last Name & Degree
Christophe Attencourt, MD
First Name & Middle Initial & Last Name & Degree
Antoine Galmiche

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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