RecruitingNot ApplicableNCT06425146
Tobacco, Alcohol and Cancerization of the Oral Mucosa (TACO)
Clinical-biological, Prospective, Monocentric Cohort Study to Describe Somatic Mutations in Healthy Oral Mucosa From Patients With Oral Squamous Cell Carcinoma (OSCC)
Sponsor
Centre Leon Berard
Enrollment
30 participants
Start Date
Aug 9, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The goal of this project is to describe somatic mutations of healthy oral mucosa from patients with oral squamous cell carcinoma (OSCC).
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria7
- 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.
Interventions
PROCEDURECytobrush sample
Healthy oral mucosa will be collected using a cytobrush, which is a minimally invasive method for patients
PROCEDUREBlood sampling
Blood sampling (6 mL), taken from a routine biological exam
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06425146