Actively Recruiting
Epigenetic Biomarkers in the Saliva for the Diagnosis of Squamous Cells Carcinoma of the Oral Cavity
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2026-05-13
60
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to improve the diagnosis of oral squamous cell carcinoma (OSCC), a type of head and neck cancer affecting the mouth. OSCC is linked mainly to tobacco and alcohol use and has a low five-year survival rate of about 60%. Early detection is challenging, especially when oral premalignant lesions are present. The study focuses on identifying saliva-based DNA methylation markers that could help detect OSCC more precisely and support personalized treatment approaches. The study will analyze saliva samples from 30 OSCC patients scheduled for primary surgical removal of their tumors and compare their DNA methylation profiles with those of control participants without head and neck cancer. Saliva samples will be collected before surgery and again about four weeks after surgery for the OSCC patients to observe changes in the epigenetic markers. Researchers will focus on a signature of four specific genes whose methylation is linked to cancer cells, identified through advanced genetic analyses. Participants will provide saliva samples during routine hospital visits. The study will measure the percentage of methylated genes in both OSCC patients and controls over one year. This includes assessing changes before and after surgery in the patient group. The research involves monitoring DNA methylation patterns to evaluate their potential as diagnostic biomarkers, aiming ultimately to enhance early OSCC detection and treatment monitoring.
CONDITIONS
Brief Title
Epigenetic Biomarkers in the Saliva for the Diagnosis of Squamous Cells Carcinoma of the Oral Cavity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients treated for histologically confirmed squamous cell carcinoma of the oral cavity
- Patients scheduled for primary surgical treatment decided by a multidisciplinary team
- Patients not previously treated surgically or with neoadjuvant therapy
- Patients aged 18 years or older
- Patients who have given written informed consent
- Patients covered by a social security scheme
- Control patients without head and neck cancer from the same surgery department
- Control patients aged 18 years or older
- Control patients who have given written informed consent
- Control patients covered by a social security scheme
- Control group matched to patient group by age, sex, tobacco, and alcohol use
You will not qualify if you...
- Patients with other types of cancer
- Patients younger than 18 years
- Pregnant or breastfeeding women
- Patients under guardianship, curatorship, legal protection, or deprived of liberty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At enrollment
Participants provide saliva samples for epigenetic biomarker analysis before surgery or at baseline for controls.
1 visit (in-person)
Duration - 4 weeks after surgery
For OSCC patients, a second saliva sample is collected during a routine hospital visit 4 weeks after surgery.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Amiens University Hospital
Amiens, Picardie, France, 80054
Actively Recruiting
Research Team
Z
Zuzana SAIDAK, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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