## Protocol Section
### Identification Module
**NCT ID:** NCT06425146

**Acronym:** TACO

**Brief Title:** Tobacco, Alcohol and Cancerization of the Oral Mucosa (TACO)

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

#### Organization Study ID Info
**ID:** ET23-384 TACO
#### Organization
**Class:** OTHER
**Full Name:** Centre Leon Berard
### Status Module
#### Completion Date
**Date:** 2025-09-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-17

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Leon Berard

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

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

**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.

### Conditions Module

**Conditions:**

- Oral Squamous Cell Carcinomas

**Keywords:**

- Somatic mutations

- Healthy oral mucosa

- oral cancer

- OSCC

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** 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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Procedure: Cytobrush sample

- Procedure: Blood sampling

**Label:** Clinical-biological cohort

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Clinical-biological cohort

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

**Name:** Cytobrush sample

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Clinical-biological cohort

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

**Name:** Blood sampling

**Type:** PROCEDURE

### Outcomes Module

#### Other Outcomes

**Description:** Selective advantage of the 62 driver genes already identified

**Measure:** Selective advantage of OSCC driver mutations in normal-looking mucosa

**Time Frame:** 1 year

**Description:** Selective advantage of non-driver OSCC genes

**Measure:** Non-drivers OSCC genes under positive selection in normal looking mucosa

**Time Frame:** 1 year

#### Primary Outcomes

**Description:** Identified mutations described by type and number

**Measure:** 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

#### Secondary Outcomes

**Description:** Correlation between tobacco consumption and total number of somatic mutations detected

**Measure:** 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

**Description:** Correlation between alcohol consumption and total number of somatic mutations

**Measure:** 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

### Eligibility Module

**Eligibility 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** philippe.zrounba@lyon.unicancer.fr

**Name:** Philippe Zrounba, M.D.

**Phone:** (0)4 69 85 60 82

**Phone Ext:** +33

**Role:** CONTACT

**Contact 2:**

**Email:** pierre.martinez@lyon.unicancer.fr

**Name:** Pierre Martinez, Ph.D.

**Phone:** (0)4 69 85 60 82

**Phone Ext:** +33

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Lyon

**Contacts:**

***Contact 1:***

- **Email:** philippe.zrounba@lyon.unicancer.fr

- **Name:** Philippe Zrounba, M.D.

- **Role:** CONTACT

**Country:** France

**Facility:** Centre Léon Bérard

**Zip:** 69008

#### Overall Officials

**Official 1:**

**Affiliation:** philippe.zrounba@lyon.unicancer.fr

**Name:** Philippe Zrounba, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000018307

- Term: Neoplasms, Squamous Cell

- ID: D000006258

- Term: Head and Neck Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M5550

- Name: Carcinoma, Squamous Cell

- Relevance: HIGH

- As Found: Squamous Cell Carcinoma

- ID: M12022

- Name: Mouth Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M1689

- Name: Squamous Cell Carcinoma of Head and Neck

- Relevance: HIGH

- As Found: Oral Squamous Cell Carcinoma

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M20451

- Name: Neoplasms, Squamous Cell

- Relevance: LOW

- As Found: Unknown

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: T4267

- Name: Oral Squamous Cell Carcinoma

- Relevance: HIGH

- As Found: Oral Squamous Cell Carcinoma

- ID: T4265

- Name: Oral Cancer

- Relevance: LOW

- As Found: Unknown

- ID: T3466

- Name: Lip and Oral Cavity Cancer

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000002294

- Term: Carcinoma, Squamous Cell

- ID: D000077195

- Term: Squamous Cell Carcinoma of Head and Neck

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M3777

- Name: Ethanol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
