SANTORIN - Monitoring antiangiogenic agents in real-life conditions of use for renal cancer
Head :
Fourrier-Reglat Annie, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Moore Nicholas, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Moore Nicholas, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Last update : 10/28/2019 | Version : 4 | ID : 2857
| General | |
| Identification | |
| Detailed name | Monitoring antiangiogenic agents in real-life conditions of use for renal cancer |
| Sign or acronym | SANTORIN |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCTI-RS 08.023, CNIL 908094 |
| General Aspects | |
| Medical area |
Cancer research |
| Health determinants |
Iatrogenic Medicine |
| Keywords | Metastatic renal cancer, antiangiogenic, first line, toxicity, tolerance, survival, conditions of use, targeted therapy, pharmacoepidemiology, cohort, Department of Pharmacology, Bordeaux |
| Scientific investigator(s) (Contact) | |
| Name of the director | Fourrier-Reglat |
| Surname | Annie |
| Address | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Phone | + 33 (0)5 57 57 46 75 |
| annie.fourrier@pharmaco.u-bordeaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Name of the director | Moore |
| Surname | Nicholas |
| Address | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Phone | + 33 (0)5 57 57 46 75 |
| nicholas.moore@pharmaco.u-bordeaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Collaborations | |
| Participation in projects, networks and consortia |
No |
| Funding | |
| Funding status |
Mixed |
| Details | Pfizer France (unconditional support) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| 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 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. | Patients were included retrospectively on the 1 January 2008 or prospectively from this date by hospital physicians prescribing antiangiogenic agents. |
| Database objective | |
| Main objective | The main objective is to estimate the overall survival at 24 months of patients with metastatic renal cancer, treated by first line antiangiogenic agents in real-life and investigate (for products for which sufficient data have been collected) if this differs from that reported in pivotal clinical trials that contributed to market authorisation. |
| Inclusion criteria | Patient with metastatic renal cancer receiving first-line treatment who began treatment with antiangiogenic agent during the inclusion period (whether or not treatment was continued or not); Patient previously unexposed to antiangiogenic agent, including during a clinical trial or Temporary Authorisation for Use; Patient able to be followed for 2 years; Patient treated with an antiangiogenic agent marketed more than 6 months in France; Patient not participating in a clinical trial; Patient not affected by a language barrier (unable to read the information letter or complete the self-administered questionnaire); Patient not objecting to data collection. |
| 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 |
| Pathology | C00-C75 - Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Hospital physicians prescribing antiangiogenic agents in France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 05/2009 |
| Date of last collection (YYYY or MM/YYYY) | 05/2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 522 patients identifiés, 390 patients inclus - 522 patients identified, of which 390 patients were included |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Paper self-questionnaire |
| 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 | Clinical and antiangiogenic agent use data are collected from two sources: medical records of centres responsible for monitoring of patients (eCRF complemented by an CRA) and patient paper-based self-administered questionnaire. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Continuous monitoring of first-line metastatic renal cancer treatment for up to 24 months. Data will be collected at 24 months for all patients including those who have had multiple lines of therapy (data regarding the treatment of disease, survival data). |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | https://www.ncbi.nlm.nih.gov/pubmed/28573786 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | A study report was delivered to the pharmaceutical company after validation by the study Scientific Committee. Scientific articles are currently being drafted.. Ownership of study data is the subject of an agreement between the University of Bordeaux Segalen and the pharmaceutical company. Terms for third-party access to the database are to be defined. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
