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Clinical Trial Finder

Search Results

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

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Interventional
Eligible Ages 18 Years and Over
Gender All
More 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.

Trial Details

Trial ID:

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.

NCT06425146
Phase

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.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Leon Berard
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Philippe Zrounba, M.D.
Principal Investigator Affiliation [email protected]
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Oral Squamous Cell Carcinomas
Additional Details

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 & Interventions

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

Centre Léon Bérard, Lyon, France

Status

Address

Centre Léon Bérard

Lyon, , 69008

Site Contact

Philippe Zrounba, M.D.

[email protected]

(0)4 69 85 60 82

Nearest Location

Site Contact

Philippe Zrounba, M.D.

[email protected]

(0)4 69 85 60 82


Resources

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with a healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with site contacts or other relevant parties. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage trial participants to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

The THANC Foundation is a 501(c)(3) charitable organization.

Federal Tax ID 80-0062118.

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THANC’s Mission

We are committed to supporting research and education in the early detection and treatment of thyroid and head and neck cancer; to advancing new therapeutic approaches; and to alleviating the suffering and functional impairment of patients who undergo treatment.

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