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

NCT06425146 | Recruiting

• 1 other identifier: ET23-384 TACO
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oral Squamous Cell Carcinomas

Keywords

Somatic mutations; Healthy oral mucosa; oral cancer; OSCC

Outcome Measures

Primary Outcomes (1)

• Identify somatic mutations of the driver genes from healthy oral mucosa from patients with epidermoid carcinomas of the upper aerodigestive tract

  Identified mutations described by type and number

  1 year

Secondary Outcomes (2)

• Correlation between tobacco consumption and the total number of somatic mutations detected in the healthy oral mucosa in patients with OSCC

  1 year

• Correlation between alcohol consumption and the total number of somatic mutations detected in the healthy oral mucosa in patients with OSCC

  1 year

Other Outcomes (2)

• Selective advantage of OSCC driver mutations in normal-looking mucosa

  1 year

• Non-drivers OSCC genes under positive selection in normal looking mucosa

  1 year

Study Arms (1)

Clinical-biological cohort

OTHER

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; Procedure: Blood sampling

Interventions

Cytobrush sample PROCEDURE

Healthy oral mucosa will be collected using a cytobrush, which is a minimally invasive method for patients

Clinical-biological cohort

Blood sampling PROCEDURE

Blood sampling (6 mL), taken from a routine biological exam

Clinical-biological cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, 69008, France

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Philippe Zrounba, M.D.

  philippe.zrounba@lyon.unicancer.fr

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Zrounba, M.D.

CONTACT

(0)4 69 85 60 82; philippe.zrounba@lyon.unicancer.fr

Pierre Martinez, Ph.D.

CONTACT

(0)4 69 85 60 82; pierre.martinez@lyon.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A clinical-biological cohort of patients with epidermoid carcinomas of the oral cavity. Blood sample and cytobrush sample at inclusion and before anti-cancer treatment.

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start: August 9, 2024
• Primary Completion: July 15, 2025
• Study Completion: September 15, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-05

Locations

FR (1)