Tobacco, Alcohol and Cancerization of the Oral Mucosa (TACO) (TACO)

August 20, 2024 updated by: Centre Leon Berard

Clinical-biological, Prospective, Monocentric Cohort Study to Describe Somatic Mutations in Healthy Oral Mucosa From Patients With Oral Squamous Cell Carcinoma (OSCC)

The goal of this project is to describe somatic mutations of healthy oral mucosa from patients with oral squamous cell carcinoma (OSCC).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify somatic mutations of the driver genes from healthy oral mucosa from patients with epidermoid carcinomas of the upper aerodigestive tract
Time Frame: 1 year
Identified mutations described by type and number
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between tobacco consumption and the total number of somatic mutations detected in the healthy oral mucosa in patients with OSCC
Time Frame: 1 year
Correlation between tobacco consumption and total number of somatic mutations detected
1 year
Correlation between alcohol consumption and the total number of somatic mutations detected in the healthy oral mucosa in patients with OSCC
Time Frame: 1 year
Correlation between alcohol consumption and total number of somatic mutations
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Selective advantage of OSCC driver mutations in normal-looking mucosa
Time Frame: 1 year
Selective advantage of the 62 driver genes already identified
1 year
Non-drivers OSCC genes under positive selection in normal looking mucosa
Time Frame: 1 year
Selective advantage of non-driver OSCC genes
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Investigators

  • Principal Investigator: Philippe Zrounba, M.D., philippe.zrounba@lyon.unicancer.fr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2024

Primary Completion (Estimated)

July 15, 2025

Study Completion (Estimated)

September 15, 2025

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ET23-384 TACO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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