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NCT Number: NCT05791149

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

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.

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Key information

Conditions

Oral Squamous Cell Carcinoma Biomarkers Carcinoma Carcinoma, Squamous Cell DNA Methylation Epigenetics Head and Neck Neoplasms Maxillo-facial Surgery Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Saliva Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amiens University Hospital

Amiens, Picardie, 80054, France

Location status: Recruiting

Location contact

Antoine Galmiche

SUB_INVESTIGATOR

Christophe Attencourt, MD

SUB_INVESTIGATOR

Stéphanie Dakpé, Pr

SUB_INVESTIGATOR

Sylvie Testelin, Pr

SUB_INVESTIGATOR

Zuzana Saidak, MD

CONTACT

[email protected]

03 22 08 70 84

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

saliva tube

Diagnostic Test

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 outcomes

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

    Time frame: one year

Secondary outcomes

  1. Percentage of methylated gene in OSCC patients before surgery

    Time frame: one year

  2. Percentage of methylated gene in OSCC patients after surgery

    Time frame: one year

Study contacts

Contact information is provided by the study sponsor or research team.

Zuzana SAIDAK, PhD

CONTACT

[email protected]

03 22 08 70 84

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: EPSACO

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2023
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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