Cohort of patients overexposed during a course of conformal radiotherapy for a prostate adenocarcinoma in Jean Monnet Hospital in Epinal / Epidemiologie - France Portal

ITMO public health Aviesan

Records Cohort of patients overexpo...

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

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

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

Export to XML

Export to CSV

General

Main features

Data collection

Promotion and access

XXX