ITMO public health
Last update : 07/10/2013 | Version : 1 | ID : 5802
| General | |
| Identification | |
| Detailed name | Iatrogenic effects in long-term following radiotherapy for a childhood skin hemangioma at Gustave Roussy between 1941 and 1973 |
| Sign or acronym | ANGIO |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL (999102); Arrêté ministériel (MESP992342A, JO du 13/11/99) |
| General Aspects | |
| Medical area |
Cancer research Cardiology |
| Others (details) | hemangioma; thyroid adenomas; carcinomas; breast cancer; malignant melanoma |
| Keywords | hemangioma in childhood, late effects, radiotherapy, iatrogenic effects, adults |
| Scientific investigator(s) (Contact) | |
| Name of the director | De Vathaire |
| Surname | Florent |
| Address | 94800 Villejuif |
| Phone | +33 (0)1 42 11 54 57 |
| florent.devathaire@gustaveroussy.fr | |
| Unit | Unité 1018/CESP équipe 3 |
| Organization | INSERM |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | FCCSS, EpiRadBio, CerebRad, Pirates, Swedish and French cohort of patients irradiated for hemangioma in childhood |
| Funding | |
| Funding status |
Mixed |
| Details | The Foundation de France, La Ligue nationale contre le cancer, Électricité de France |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM |
| 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 study aims to evaluate the consequences in long-term that can be caused by radiation in hemangioma childhood, treated between 1941 and 1973 in Gustave Roussy (France). The main objective of the study is to inform the patients about the treatment they had received so that they can inform their physician. Another objective is to estimate the mortality by cancer and the incidence of cancers (including thyroid and breast cancer, two of the most radiosensitive organs) taking into account the dose of ionizing radiation received at the site of the tumor. |
| Inclusion criteria | patients treated by radiotherapy for childhooh hemangioma |
| 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) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
Local |
| Detail of the geography area | Gustave Roussy |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/1985 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 8320 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Information collected from medical records: hemangioma characteristics, family history, type of radiotherapy/treatment, duration of radiotherapy/treatment |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Details of collected declarative data | Information collected from medical records: hemangioma characteristics, family history, type of radiotherapy/treatment, duration of radiotherapy/treatment |
| Paraclinical data (detail) | Imaging: estimation of 188 points human body radiation dosimetry. |
| Administrative data (detail) | Identifying data |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Participant monitoring |
Yes |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | vital status, causes of death if deceased |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/19515442 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/20607383 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/22082956 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/15236880 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/11131186 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/10075261 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data can be used (conditions for access to define) |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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