NCT05791149 Epigenetic Biomarkers in the Saliva for the Diagnosis of Squamous Cells Carcinoma of the Oral Cavity
| NCT ID | NCT05791149 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Oral Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-03-03 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-03-03 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05791149 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oral Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05791149 currently recruiting?
Yes, NCT05791149 is actively recruiting participants. Contact the research team at saidak.zuzana@chu-amiens.fr for enrollment information.
Where is the NCT05791149 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT05791149 clinical trial?
NCT05791149 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 60 participants.