ITMO public health
Last update : 08/06/2015 | Version : 3 | ID : 6502
| General | |
| Identification | |
| Detailed name | Cohort of Cihldren with Second Cancer: Long-Term Iatrogenic Effects from Treatment |
| Sign or acronym | Euro2K |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL authorisation request: No. 902287 |
| General Aspects | |
| Medical area |
Cancer research |
| Health determinants |
Addictions Iatrogenic Occupation |
| Keywords | solid cancer, radiotherapy, iatrogenic effect, dosimetry, social outcome, second cancer, child |
| Scientific investigator(s) (Contact) | |
| Name of the director | De Vathaire |
| Surname | Florent |
| Address | B2M - 114 rue Edouard Vaillant - 94805 Villejuif |
| Phone | + 33 (0)1 42 11 54 57 |
| florent.devathaire@gustaveroussy.fr | |
| Organization | Institut National de la Santé et de la Recherche |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Wyeth Foundation, INSERM, IReSP. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Institut National de la Santé et de la Recherche Médicale |
| 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. | Solid cancer treatment cases for children under 15 years of age are recorded by consulting archives from 8 French and English healthcare institutions. |
| Database objective | |
| Main objective | To quantify the long-term iatrogenic effects of childhood cancer treatment. |
| Inclusion criteria |
- Children/adolescents under 15 years old at time of diagnosis;
- Treated for solid cancer in 8 healthcare institutions in France and England; - Diagnosed with solid cancer before 1986. |
| 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 |
International |
| Detail of the geography area | - Great Britain (3 hospitals in London) - France (5 cancer treatment centres: Gustave Roussy, Curie Institute in Paris, Jean Godinot Institute in Reims, Claudius Régaud Institute in Toulouse, Antoine Lacassagne Centre in Nice). |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 1985 |
| Date of last collection (YYYY or MM/YYYY) | 2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 4,500 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures |
| Details of collected clinical data | Medical records from cancer treatment centres, medical data collected from individuals/healthcare professionals. |
| Declarative data (detail) |
Paper self-questionnaire |
| Details of collected declarative data | The questionnaire is completed by subjects providing information on occupation, social status, integration, family and professional networks, housing, access to bank loans, fertility, offspring, medical problems, access to healthcare, treatment, treatment plan and continuation between childhood and adulthood. |
| Biological data (detail) | Biological analysis results (e.g., anatomopathological report). |
| Administrative data (detail) | Personal identification data (civil status, gender, date of birth, place of birth) collected indirectly from different administrative medical data source and directly from subjects in the study. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | The cohort was created between 1985 and 1995 from medical records in 8 centres. An estimation of ionising radiation dosage to all organs inside or outside radiotherapy was conducted between 1992 and 1997. A secondary cancer study was begun in 1995 from single monitoring collected in medical records. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Morbidity and mortality are monitored regularly for the entire cohort by cross-referencing administrative medical sources. Follow-up is also carried out by self-administered questionnaire. |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | French National Directory of Individuals - RNIPP INSEE and CépiDc INSERM, postal service. |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Publis-HAL-FCCSS-EURO2K |
| Description | List of publications in HAL |
| Link to the document | http://tinyurl.com/Pubmed-FCCSS-EURO2K |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | The use of anonymised data is possible for all research teams with recognised experience in the specialist field. Usage is decided on a case-by-case basis and regulated by agreement. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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