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