- ONCOTAB
Head :
Biau David, UMR 1153 intégré dans le centre de recherche Epidémiologies et Biostatistique Sorbonne Paris Cité. Equipe ECaMO
Last update : 07/05/2014 | Version : 1 | ID : 8142
| General | |
| Identification | |
| Detailed name | ONCOTAB |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Autorisations CPP, CNIL, CCTIRS en cours. |
| General Aspects | |
| Medical area |
Cancer research |
| Health determinants |
Geography Occupation Social and psychosocial factors |
| Others (details) | Bone and soft tissue cancer |
| Keywords | Bone sarcoma, socio-economic, geographical, professional, factors, life components, distant recurrence, overall survival, social impact, social, psychological, local recurrence, questionnaire, PROMIS. |
| Scientific investigator(s) (Contact) | |
| Name of the director | Biau |
| Surname | David |
| Address | Dr David Biau. Service de Chirurgie Orthopédique et Oncologique. Hôpital Cochin. 27 rue du faubourg Saint-Jacques. 75014 Paris, France |
| Phone | +33 (0) 1 58 41 40 52 |
| david.biau@cch.aphp.fr | |
| Unit | UMR 1153 intégré dans le centre de recherche Epidémiologies et Biostatistique Sorbonne Paris Cité. Equipe ECaMO |
| Organization | Université Paris Descartes, APHP |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | Recherche de financements en cours |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Université Paris Descartes |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | AP-HP |
| Organisation status |
Public |
| 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) |
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. | All sarcoma cases within the surgery, oncology and radiotherapy units of the sarcoma multidisciplinary meeting (Réunion de Concertation Pluridisciplinaire) in Cochin are eligible for the study. |
| Database objective | |
| Main objective | The main objective of this cohort is to evaluate the impact of social factors on physical, psychological, social, financial and professional life components for patients with sarcomas. Secondary objectives: - to identify the impact of social factors that affect patients before diagnosis and during follow-up - to identify the impact of social factors on oncological results such as: local recurrence, distant recurrence and overall survival - to evaluate patients' impressions on the use of digital tablets and ePROS collection during consultation - to identify social challenges and implications (domestic life, family life, marital life, social skills, leisure and professional activities) considered important by patients and that they feel were inadequately or insufficiently explored by the PROMIS questionnaires |
| Inclusion criteria | Inclusion criteria: - over the age of 18 - diagnosed with sarcoma (made by multidisciplinary meeting teams or a RRePS network team) - no treatment has commenced |
| 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 |
Local |
| French regions covered by the database |
Île-de-France |
| Detail of the geography area | Hôpital Cochin Paris |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/2014 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | --- |
| Data | |
| Database activity |
Current data collection |
| 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 | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 18 months |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| 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 |
