Understanding mutations in healthy oral tissue of patients with oral cancer
Clinical-biological, Prospective, Monocentric Cohort Study to Describe Somatic Mutations in Healthy Oral Mucosa From Patients With Oral Squamous Cell Carcinoma (OSCC)
This study is trying to find genetic changes in healthy mouth tissue from patients with oral cancer to see if they can help with early diagnosis and better treatment options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Leon Berard Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lyon) |
| Trial ID | NCT06425146 on ClinicalTrials.gov |
What this trial studies
This project aims to investigate somatic mutations in healthy oral mucosa from patients diagnosed with oral squamous cell carcinoma (OSCC). By analyzing cytobrush samples and blood samples, the study seeks to identify potential biomarkers that could aid in early diagnosis and prognosis of OSCC. Given the high incidence and poor survival rates associated with these cancers, the research focuses on understanding the genetic changes that may occur even in non-cancerous tissue. The findings could lead to improved screening methods and treatment strategies for patients at risk of developing OSCC.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a histological diagnosis of epidermoid carcinoma of the oral cavity who have not received any systemic anti-cancer treatment.
Not a fit: Patients with bleeding disorders or those who have undergone surgery for their oral carcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and better prognostic tools for patients at risk of oral squamous cell carcinoma.
How similar studies have performed: While there have been studies investigating mutations in cancerous tissues, this approach focusing on healthy mucosa as a potential biomarker source is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * I1. Male or female aged 18 years or older at the date of signature of the informed consent to participate. * I2. Patient with histological diagnosis of epidermoid carcinomas of the oral cavity NB: All grades are eligible. * I3. Patient naive of any systemic anti-cancer treatment (radio- or chemotherapy). * I4. Patient able to understand, sign and date informed consent before the start of any study protocol procedure. * I5. Patient affiliated or covered by a medical insurance Exclusion Criteria: * E1. Patients at high risk of bleeding, such as those on anticoagulant or antiplatelet aggregant treatment, with clotting disorders or a history of severe bleeding in the two weeks prior to inclusion. * E2. Patient with lesions of all types on the mucosa of the cheek located on the opposite side of the area affected by an epidermoid carcinoma of the oral cavity which prevents painless removal of the healthy mucosa. * E3. Patient who had surgery for their epidermoid carcinoma of the oral cavity more than 6 months ago. * E4. Patient who uses cannabis. * E5. Patient with another active tumor or HPV-positive tumors. * E6. Patient under guardianship or curatorship or placed under the protection of justice. * E7. Pregnant and/or nursing patient.
Where this trial is running
Lyon
- Centre Léon Bérard — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Philippe Zrounba, M.D. — philippe.zrounba@lyon.unicancer.fr
- Study coordinator: Philippe Zrounba, M.D.
- Email: philippe.zrounba@lyon.unicancer.fr
- Phone: (0)4 69 85 60 82
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.