Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425146
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-17
Brief Title:
Tobacco Alcohol and Cancerization of the Oral Mucosa TACO
Sponsor:
Centre Leon Berard
Organization:
Centre Leon Berard
Study Overview
Official Title:
Clinical-biological Prospective Monocentric Cohort Study to Describe Somatic Mutations in Healthy Oral Mucosa From Patients With Oral Squamous Cell Carcinoma OSCC
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TACO
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 500000 cases per year and 20000 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 13 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 cavitys 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
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 13 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 cavitys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None