ISICA - Case-Control Study on the Risk of Breast Cancer through Insulin Use 
Head :
Abenhaim Lucien
Grimaldi-Bensouda Lamiae, C121-SC of Vie-Pharma fourth group; U657 Pharmacoepidemiology and Evaluation of the Impact of Health Products on the Population—Pasteur Institute
Grimaldi-Bensouda Lamiae, C121-SC of Vie-Pharma fourth group; U657 Pharmacoepidemiology and Evaluation of the Impact of Health Products on the Population—Pasteur Institute
Last update : 01/01/2019 | Version : 1 | ID : 9090
| General | |
| Identification | |
| Detailed name | Case-Control Study on the Risk of Breast Cancer through Insulin Use |
| Sign or acronym | ISICA |
| General Aspects | |
| Medical area |
Cancer research Endocrinology and metabolism Gynecology/ obstetrics |
| Pathology (details) | Breast cancer; diabetes |
| Health determinants |
Medicine |
| Keywords | hormone treatment, insulin, glargine, aspart, lispro, cancer, diabetes, contraception |
| Scientific investigator(s) (Contact) | |
| Name of the director | Abenhaim |
| Surname | Lucien |
| lucien.abenhaim@la-ser.com | |
| Organization | La-Ser |
| Name of the director | Grimaldi-Bensouda |
| Surname | Lamiae |
| Address | 146 rue Léo Saignat C121-SC of Vie-Pharma fourth group 33076 BORDEAUX |
| Phone | +33 (0)1 45 68 82 27 |
| Lamiae.Grimaldi@la-ser.com / lamiae.grimaldi@pgrx.net | |
| Unit | C121-SC of Vie-Pharma fourth group; U657 Pharmacoepidemiology and Evaluation of the Impact of Health Products on the Population—Pasteur Institute |
| Organization | La-Ser |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Sanofi-Aventis, La-Ser |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Sanofi-Aventis |
| Organisation status |
Private |
| Sponsor(s) or organisation(s) responsible | La-Ser |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Case control study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. |
The case-control study was conducted using data collected from 92 major breast cancer treatment centres throughout France, United Kingdom and Canada, as well as data from treating physicians, prescriptions and the patients themselves in order to minimise bias.
775 patients were selected from the hospital records for 40,000 patients diagnosed with breast cancer between 01 January 2008 and 30 June 2009 (89% primary invasive cancer, 47% TNM 1, 30% TNM2, 64% luminal tumours). Out of these 40,000 patients, diabetes cases were identified from anaesthesia records and confirmation of the disease by the patients themselves. 41% of these patients were eligibles and participated in the study. In all, 6.2% were living and being treated for diabetes. Cancer-free diabetic controls were enrolled by their physicians (582 physicians) and matched according to age, recruitment date, country or region of origin, type of diabetes and management type. |
| Database objective | |
| Main objective | The aim is to assess the possible relation between using individual insulins (duration of exposure, administered dosage) and increased breast cancer risk. |
| Inclusion criteria |
For case subjects:
– Breast cancer diagnosed between 01 January 2008 and 30 June 2009 – Diabetes confirmed by the patient and anaesthesia records. For controls: – No breast cancer – Diabetes confirmed by the patient and anaesthesia records |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Gender |
Woman |
| Geography area |
International |
| Detail of the geography area | France; Canada; United Kingdom |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2008 |
| Date of last collection (YYYY or MM/YYYY) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 3,825 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures |
| Details of collected clinical data | History of diabetes; risk factor; prescriptions; data; detailed data on diabetes (type, age at diagnosis, duration, antidiabetes treatments); complications (renal, vascular, ophthalmological, and neurological). Information on history of breast and ovarian cancer; insulin therapy (glargine, aspart, lispro, and human insulin); hormone replacement therapy; motherhood; first menstruation; menopause; breastfeeding and oral contraception. Exposure to insulin. |
| Declarative data (detail) |
Phone interview |
| Details of collected declarative data | Education; socioeconomic status; smoking, alcohol consumption and physical activity |
| Paraclinical data (detail) | Anaesthesia records for presence of diabetes. |
| Biological data (detail) | HbA1c |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health care consumption and services |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23949559 |
| Link to the document | http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2961374-8/fulltext |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
