Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05791149

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - At enrollment

Participants provide saliva samples for epigenetic biomarker analysis before surgery or at baseline for controls.

1 visit (in-person)

Diagnostic Evaluation

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

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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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