EpiHadron - Incidence study with population of Rhone-Alpes region of cancers eligible for hadrontherapy by proton or carbon ions. Description of Tumors and patients characteristics

Head :
Pommier Pascal
Patin Stéphanie

Last update : 08/05/2015 | Version : 4 | ID : 2995

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Incidence study with population of Rhone-Alpes region of cancers eligible for hadrontherapy by proton or carbon ions. Description of Tumors and patients characteristics
Sign or acronym EpiHadron
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL : 1435497
General Aspects
Medical area Cancer research
Otolaryngology or ENT
Health determinants Iatrogenic
Keywords hadrontherapy, descriptive prospective survey, evaluation., Epidemiology, incidence, ENT
Scientific investigator(s) (Contact)
Name of the director Pommier
Surname Pascal
Email pommier@lyon.fnclcc.fr
Organization Centre Léon Bérard
Name of the director Patin
Surname Stéphanie
Organization GCS ( Groupment de Coopération Sanitaire) ETOILE
Collaborations
Funding
Funding status Private
Details GCS ETOILE
Governance of the database
Sponsor(s) or organisation(s) responsible Promoteur : GCS ETOILE, 60 avenue Rockefeller, 69008, Lyon.
Organisation status Public
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Longitudinal study (except cohorts)
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is carried out as part of an interventional study No
Database objective
Main objective The main objective is to evaluate in the Rhône-Alpes region the incidence of cancers that have an indication eligible for treatment with hadrontherapy by proton or carbon ions.
Inclusion criteria Type of tumors to identify:
A list of the main indications for hadrontherapy by protons and by carbon ions (Appendix 1: list of indications) was developed by experts using data from literature prioritized according to an ""evidence based medicine"" type analysis and based on rendered or expected service criteria (survival and quality of life), (Appendix 2: Literature review method).

Criteria for ""patient"" inclusion
The study will be carried out with adult and child subjects, with no age limit, who have indications of hadrontherapy, whose dossiers were able to be discussed by experts at a preliminary pluridisciplinary concertation meeting (RCP).
Subjects must have a general and psychological condition that is compatible with hadrontherapy (good compliance, possible follow-up, accept to travel where applicable) and absence of co-morbidities that are life-threatening.

Criteria for ""tumor"" inclusion
The characteristics common to the pathologies to be identified are as follows:
Inoperable tumors, which belong to a pathological group recognized as radio-resistant, at the early stage of development (locoregional stage) or recurring or local relapse, with a low metastatic potential or with an M+ dissemination controlled by medical treatments.

Criteria for exclusion
Tumors: Choroidal melanomas are excluded from the study.
Patients: General or psychological condition that is not compatible or threatening co-morbidities.
Population type
Age Newborns (birth to 28 days)
Infant (28 days to 2 years)
Early childhood (2 to 5 years)
Childhood (6 to 13 years)
Adolescence (13 to 18 years)
Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Great age (80 years and more)
Population covered Sick population
Gender Male
Woman
Geography area Regional
French regions covered by the database Auvergne Rhône-Alpes
Detail of the geography area Rhône-Alpes
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2010
Date of last collection (YYYY or MM/YYYY) 2012
Size of the database
Size of the database (number of individuals) [500-1000[ individuals
Details of the number of individuals 800
Data
Database activity Current data collection
Type of data collected Clinical data
Biological data
Administrative data
Clinical data (detail) Medical registration
Biological data (detail) anatomopathological results
Administrative data (detail) monogram
Presence of a biobank No
Health parameters studied Health event/morbidity
Health care consumption and services
Others
Care consumption (detail) Hospitalization
Medical/paramedical consultation
Other (detail) 1) Characteristics of the tumors: therapeutic status, recurrence situation, initial stage of the tumor, treatments received before recurrence, timeframe recurrence occurred, current stage of the tumor, ICD 10 code, ICDO histological type, treatment prior to preliminary pluridisciplinary concertation (RCP), site of surgery and the margins, pTNM, external radiotherapy, therapeutic strategy considered by the RCP; 2) Characteristics of the patients; 3) Care of the preliminary pluridisciplinary concertation meeting type.
Procedures
Data collection method prospective, continuous
Participant monitoring No
Links to administrative sources No
Promotion and access
Promotion
Link to the document http://tinyurl.com/Hal-EPIHADRON
Description List of publications in HAL
Link to the document http://tinyurl.com/Pubmed-Publis-EPIHADRON
Description List of publications in Pubmed
Access
Terms of data access (charter for data provision, format of data, availability delay) publication of articles
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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