Clinical Trial Finder
Tobacco, Alcohol and Cancerization of the Oral Mucosa (TACO)
Study Purpose
The goal of this project is to describe somatic mutations of healthy oral mucosa from patients with oral squamous cell carcinoma (OSCC).
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
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.Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Epidermoid carcinomas of upper aerodigestive tract are the 8th most common cancers in the world. Worldwide, this represents more than 500.000 cases per year and 20.000 cases per year in France (statistics 2018-2020). Among these cancers, oral squamous cell carcinoma (OSCC) are the most common location, leading to significant morbidity and mortality. Despite recent advances in diagnosis, treatment and monitoring, the overall 5-year survival rate of patients with epidermoid carcinomas of upper aerodigestive tract has not improved significantly and remains around 40-50 % for all combined locations. These pejorative survival rates, as well as the increase in the incidence of these cancers, have not changed much over the past 30 years. This situation can be attributed in part to a diagnosis too late. Indeed, only 1/3 of patients with high-risk squamous cell carcinoma of the head and neck are diagnosed at an early stage. This issue of early diagnosis is mainly due to the lack of suitable screening and diagnostic biomarkers. Beyond diagnosis, the identification of biomarkers is also a prognostic and predictive interest since they could predict the course of the disease as well as the response to treatment. "Drivers" mutations, with oncogenic potential, can be present from the very early stages of epidermoid carcinomas of upper aerodigestive tract and therefore constitute potential biomarkers. However, recent studies have demonstrated the presence of driver mutations in different types of oral cavity's healthy tissue, some being even associated with a protective effect against tumor initiation. In order to improve prevention and early diagnosis of OSCC, it is important to better understand the evolutionary dynamics of somatic mutations in the oral mucosa, which is still poorly characterized.
Arms
Other: Clinical-biological cohort
A clinical-biological cohort of 30 patients with epidermoid carcinomas of the oral cavity. Blood sample and cytobrush sample at inclusion and before anti-cancer treatment.
Interventions
Procedure: - Cytobrush sample
Healthy oral mucosa will be collected using a cytobrush, which is a minimally invasive method for patients
Procedure: - Blood sampling
Blood sampling (6 mL), taken from a routine biological exam
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Address
Centre Léon Bérard
Lyon, , 69008
Site Contact
Philippe Zrounba, M.D.
[email protected]
(0)4 69 85 60 82
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