Oral Squamous Cell CarcinomasTACONCT06425146
Tobacco, Alcohol and Cancerization of the Oral Mucosa (TACO)
A study testing Cytobrush sample and Blood sampling in people with Oral Squamous Cell Carcinomas, run by Centre Leon Berard at 1 site in France.
Trial summary
The goal of this project is to describe somatic mutations of healthy oral mucosa from patients with oral squamous cell carcinoma (OSCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Squamous Cell Carcinomas
- What is being tested?
- Cytobrush sample and Blood sampling
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 9 Aug 2024to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Léon Bérard
Lyon, 69008
Philippe Zrounba, M.D., philippe.zrounba@lyon.unicancer.fr
About this study
Official title: 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).
Read the 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
- Oral Squamous Cell Carcinomas
- Being tested
- Cytobrush sample, Blood sampling
- Keywords
- Somatic mutations, Healthy oral mucosa, oral cancer, OSCC
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytobrush sampleProcedure or surgery
Healthy oral mucosa will be collected using a cytobrush, which is a minimally invasive method for patients
Blood samplingProcedure or surgery
Blood sampling (6 mL), taken from a routine biological exam
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Cytobrush sample; Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Correlation between tobacco consumption and total number of somatic mutations detected
Measured: 1 year
Correlation between alcohol consumption and the total number of somatic mutations detected in the healthy oral mucosa in patients with OSCC
Correlation between alcohol consumption and total number of somatic mutations
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start9 Aug 2024
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell CarcinomasStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Zrounba, M.D., Principal investigator, philippe.zrounba@lyon.unicancer.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425146
- Sponsor's protocol ID
- ET23-384 TACO
- Acronym
- TACO
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical-biological, Prospective, Monocentric Cohort Study to Describe Somatic Mutations in Healthy Oral Mucosa From Patients With Oral Squamous Cell Carcinoma (OSCC)
- ClinicalTrials.gov ID
- NCT06425146
- Acronym / sponsor ID
- TACO / ET23-384 TACO
- Conditions
- Oral Squamous Cell Carcinomas
- Keywords
- Somatic mutations, Healthy oral mucosa, oral cancer, OSCC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Clinical-biological cohort | Other | Procedure: Cytobrush sample, Procedure: Blood samplingA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytobrush sampleHealthy oral mucosa will be collected using a cytobrush, which is a minimally invasive method for patients | Procedure or surgery | Clinical-biological cohort |
| Blood samplingBlood sampling (6 mL), taken from a routine biological exam | Procedure or surgery | Clinical-biological cohort |
Primary outcome
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
2 secondary outcomes
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 alcohol consumption and the total number of somatic mutations detected in the healthy oral mucosa in patients with OSCC
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Zrounba, M.D. principal investigator
philippe.zrounba@lyon.unicancer.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytobrush sample and Blood sampling in people with Oral Squamous Cell Carcinomas, run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Zrounba, M.D. ((0)4 69 85 60 82 ext. +33, philippe.zrounba@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.