Saliva DNA methylation test for diagnosing oral cavity squamous cell carcinoma
Official title: Epigenetic Biomarkers in the Saliva for the Diagnosis of Squamous Cells Carcinoma of the Oral Cavity
Run by Centre Hospitalier Universitaire, Amiens · NCT05791149 · Data updated 2026-11-12
This tests whether a saliva DNA methylation test can detect oral squamous cell carcinoma in adults scheduled for maxillofacial surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens, Picardie) |
| Status | Recruiting |
| Started | March 3, 2022 |
| Main results expected | April 2027 |
| Study ends | October 2027 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT05791149 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (over 18) with a newly diagnosed, histologically confirmed oral squamous cell carcinoma who are planned for first-line surgical treatment and can provide informed consent.
✕Probably not a fit
Patients who have had prior cancer treatments, have other types of cancer, are under 18, pregnant or breastfeeding, or cannot provide a saliva sample are unlikely to benefit from this diagnostic approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will collect saliva samples from adults with histologically confirmed oral squamous cell carcinoma who are planned for primary surgery and from matched control patients in the maxillofacial service without head and neck cancer. DNA methylation patterns in saliva will be measured and compared between cancer patients and controls to identify epigenetic biomarkers that indicate malignancy. The goal is to see if a noninvasive, saliva-based methylation signature can reliably distinguish OSCC from noncancerous conditions. The work is conducted at Amiens University Hospital in a region with a high incidence of oral cancer and includes matching for age, sex, tobacco and alcohol use.
Why it matters
Potential benefit: If successful, this could enable an easy, noninvasive saliva test to help detect oral cancers earlier and guide treatment decisions.
How similar studies have gone: Prior research has shown promising salivary DNA methylation markers for oral and head-and-neck cancers, but diagnostic panels are not yet widely validated for routine clinical use.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Amiens University Hospital
Amiens, Picardie, France Recruiting
Study contacts
- Study coordinator: Zuzana SAIDAK, PhD
- Email: saidak.zuzana@chu-amiens.fr
- Phone: 03 22 08 70 84
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.