EPOPA - Cohort of patients overexposed during a course of conformal radiotherapy for a prostate adenocarcinoma in Jean Monnet Hospital in Epinal

Head :
Simon Jean-Marc, SERVICE D’ONCOLOGIE RADIOTHÉRAPIQUE GROUPE HOSPITALIER PITIÉ-SALPÊTRIÈRE 47-83 BOULEVARD DE L’HÔPITAL, 75651 PARIS CEDEX 13 AP-HP
Gourmelon Patrick, INSTITUT DE RADIOPROTECTION ET DE SÛRETÉ NUCLÉAIRE (IRSN) DIRECTION DE LA RADIOPROTECTION DE L’HOMME IRSN
Tabassome Simon, UNITÉ DE RECHERCHE CLINIQUE DE L’EST PARISIEN SERVICE DE PHARMACOLOGIE FACULTÉ DE MÉDECINE PIERRE ET MARIE CURIE UNITÉ DE RECHERCHE CLINIQUE DE L’EST PARISIEN SERVICE DE PHARMACOLOGIE FACULTÉ DE MÉDECINE PIERRE ET MARIE CURIE

Last update : 07/21/2015 | Version : 2 | ID : 60188

print
Print
xml
XML

Export to XML

Please choose the format :

pdf
PDF
xml
CSV (Excel)

Export to CSV

What sections do you want to export ?

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
Select all | Invert selection | No selection

Which version do you want to export ?

send
Send
General
Identification
Detailed name Cohort of patients overexposed during a course of conformal radiotherapy for a prostate adenocarcinoma in Jean Monnet Hospital in Epinal
Sign or acronym EPOPA
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL
General Aspects
Medical area Cancer research
Nuclear medicine
Health determinants Iatrogenic
Occupation
Keywords doses, irradiated tissues, overexposure, complications, iatrogenic effects, dosimetry
Scientific investigator(s) (Contact)
Name of the director Simon
Surname Jean-Marc
Address 75013 PARIS
Phone +33 (0)1 42 17 81 74
Email jean-marc.simon@psl.aphp.fr
Unit SERVICE D’ONCOLOGIE RADIOTHÉRAPIQUE GROUPE HOSPITALIER PITIÉ-SALPÊTRIÈRE 47-83 BOULEVARD DE L’HÔPITAL, 75651 PARIS CEDEX 13 AP-HP
Name of the director Gourmelon
Surname Patrick
Address 92262 FONTENAY-AUX-ROSES
Phone +33 (0)1 58 35 77 54
Email patrick.gourmelon@irsn.fr
Unit INSTITUT DE RADIOPROTECTION ET DE SÛRETÉ NUCLÉAIRE (IRSN) DIRECTION DE LA RADIOPROTECTION DE L’HOMME IRSN
Name of the director Tabassome
Surname Simon
Address 75012 PARIS
Phone +33 (0)1 40 01 14 57
Email tabassome.simon@sat.aphp.fr
Unit UNITÉ DE RECHERCHE CLINIQUE DE L’EST PARISIEN SERVICE DE PHARMACOLOGIE FACULTÉ DE MÉDECINE PIERRE ET MARIE CURIE UNITÉ DE RECHERCHE CLINIQUE DE L’EST PARISIEN SERVICE DE PHARMACOLOGIE FACULTÉ DE MÉDECINE PIERRE ET MARIE CURIE
Collaborations
Funding
Funding status Public
Details Programme hospitalier de recherche clinique
Governance of the database
Sponsor(s) or organisation(s) responsible APHP
Organisation status Public
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Cohort study
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
Additional information regarding sample selection. Prospective Inclusion cut-off date: 01/12/2009
Database objective
Main objective To correlate received doses and volume of irradiated normal tissues in the cohort of patients who underwent overexposure of varying degrees, as well as complications observed with biologic, phenotypic and genetic data. The incidence and severity of iatrogenic effects and sequelae of radiotherapy (according to soma-lent and CTCAE scales) are correlated using a precise reconstruction of actual irradiation dosimetry received by each patient (total radiation dose prescribed and issued by daily controls) according to technical dossier data and system treatment planning. Secondary objective: to gather biological collections from blood samples (serum bank, DNA bank, lymphocytes) to correlate iatrogenic complications and radiation doses to normal tissues with biologic, phenotypic and genetic data. These collections will be used to: - identify factors associated with susceptibility to radiation-induced complications in normal tissues; - study radiation fibrosis biology; - study normal tissue radiosensitivity: rectal wall; - study the biological control dose-response relationship for prostate adenocarcinoma; - implement radiogenic fibrosis treatment protocols.
Inclusion criteria Patients treated for a prostate adenocarcinoma in the radiation department of the Jean Monnet Hospital between 2000 and 2006.
Population type
Age 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 Departmental
French regions covered by the database Alsace Champagne-Ardenne Lorraine
Detail of the geography area Epinal Hospital, Vosges department
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 09/2008
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 120 sujets inclus avec recueil sanguin / 120 with blood sample selection409 patients concernés, dont 29 sont décédés / 409 concerned with 29 deaths
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Biological data
Clinical data (detail) Direct physical measures
Medical registration
Declarative data (detail) Face to face interview
Biological data (detail) Blood samples
Presence of a biobank Yes
Contents of biobank Serum
Plasma
Fluids (saliva, urine, amniotic fluid, …)
Tissues
DNA
Details of biobank content Serum bank, plasma bank, DNA bank, lymph bank and tissue bank (for patients who have had a rectum amputation).
Health parameters studied Health event/morbidity
Health event/mortality
Health care consumption and services
Care consumption (detail) Medical/paramedical consultation
Procedures
Data collection method Interviews: manual input from a paper questionnaire Clinical examinations: handwritten
Participant monitoring Yes
Details on monitoring of participants Duration: 5 years
Links to administrative sources No
Promotion and access
Promotion
Link to the document http://tinyurl.com/HAL-EPOPA
Description List of publications in HAL
Link to the document http://tinyurl.com/Pubmed-EPOPA
Description List of publications in Pubmed
Access
Terms of data access (charter for data provision, format of data, availability delay) To be decided if data may be used by academic teams. Data may not be used by industrial teams.
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

Partners - FAQ - Contact - Site map - Legal notices - Administration - Updated on December 15 2020 - Version 4.10.05