Ignite Creation Date:
2024-05-06 @ 8:58 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02866500
Status:
UNKNOWN
Last Update Posted:
2016-08-15
First Post:
2015-01-06
Brief Title:
Oral State of Patients Affected by an Oral Cancer Before and After Radiotherapy - 3-years Prospective Study
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Oral State of Patients Affected by an Oral Cancer Before and After Radiotherapy - 3-years Prospective Study
Status:
UNKNOWN
Status Verified Date:
2016-08
Last Known Status:
RECRUITING
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:
VADS
Brief Summary:
Context the oral cancer is the 5th cancer in order of frequency for human in France It is the country where the mortality by oral cancer is the most raised in Europe The most frequent location concerns the oral cavity prevalency of which is one of higher in the world The main risk factors are the tobacco and the alcohol
The oral cancer is treated in the great majority of the cases by radiotherapy which is going to pull xerostomy responsible for the degradation of the oral state Furthermore it will increase the risk of appearance of osteoradionecrosis ORN when the patient is carrier of buccal lesions andor when he will have to undergo surgical acts Consequently the initial oral state of the patients is to be estimated so as to eliminate any source of the infection An unfavourable initial state will increase the risk of degradation of this one and appearance of ORN However at present few epidemiological data are available concerning the oral state of the patients presenting an oral cancer
Objective the main objective of this study is to describe before radiotherapy the oral state of the patients presenting an oral cancer and to follow the evolution of this oral state for three years and to register the patients quality of life The secondary objectives are to describe the distribution of risk factors of the degradation of the oral state oral hygiene food habits xerostomy consumption of tobacco and alcohol in this population and to register the impact of the dental restorations on the radiological assessment
Methods this prospective epidemiological study of observation will be realized in the service of odontology of the Timone hospital Marseille France in association with the services of ORL and maxillofacial surgery of Timone as well as the services of radiotherapy and medical oncology of Timone and Paoli Calmettes institute IPC All the toothed patients affected by an oral cancer untreated will be included or treated surgically only of more than 18 years old and for whom an initial dental assessment will be realized The main assessment criteria will be the CAD index and the parodontal state
Expected results and perspectives This study will allow to have epidemiological data concerning patients oral state affected by an oral cancer before and after radiotherapy It will allow to set up a consensus of good practice
The oral cancer is treated in the great majority of the cases by radiotherapy which is going to pull xerostomy responsible for the degradation of the oral state Furthermore it will increase the risk of appearance of osteoradionecrosis ORN when the patient is carrier of buccal lesions andor when he will have to undergo surgical acts Consequently the initial oral state of the patients is to be estimated so as to eliminate any source of the infection An unfavourable initial state will increase the risk of degradation of this one and appearance of ORN However at present few epidemiological data are available concerning the oral state of the patients presenting an oral cancer
Objective the main objective of this study is to describe before radiotherapy the oral state of the patients presenting an oral cancer and to follow the evolution of this oral state for three years and to register the patients quality of life The secondary objectives are to describe the distribution of risk factors of the degradation of the oral state oral hygiene food habits xerostomy consumption of tobacco and alcohol in this population and to register the impact of the dental restorations on the radiological assessment
Methods this prospective epidemiological study of observation will be realized in the service of odontology of the Timone hospital Marseille France in association with the services of ORL and maxillofacial surgery of Timone as well as the services of radiotherapy and medical oncology of Timone and Paoli Calmettes institute IPC All the toothed patients affected by an oral cancer untreated will be included or treated surgically only of more than 18 years old and for whom an initial dental assessment will be realized The main assessment criteria will be the CAD index and the parodontal state
Expected results and perspectives This study will allow to have epidemiological data concerning patients oral state affected by an oral cancer before and after radiotherapy It will allow to set up a consensus of good practice
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-A01244-43 | OTHER | Ansm | None |