Last update : 07/10/2014 | Version : 1 | ID : 8130
| General | |
| Identification | |
| Detailed name | CHONSOL |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Cancer research Traumatology |
| Health determinants |
Iatrogenic |
| Keywords | Solitary chondroma, chondrosarcoma, molecular markers, home, prognostic factors of onset., RESOS |
| Scientific investigator(s) (Contact) | |
| Name of the director | Gouin |
| Surname | François |
| Address | 1 place Alexis Ricordeau – 44093 Nantes cedex 01 |
| Phone | +33 (0)2 40 08 48 43 |
| francois.gouin@chu-nantes.fr | |
| Unit | Service de chirurgie orthopédique et traumatologique du CHU Nantes |
| Organization | CHU |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | Recherche de financements en cours |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU Nantes |
| 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 An administrative base or a register |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | The main objective of the study is to determine the incidence of chondrosarcoma at 5 years in a population presenting with solitary chondroma. The secondary objectives of the study are: - To determine the incidence of chondrosarcoma at 10 years a population presenting with solitary chondroma -To describe solitary chondroma diagnosis and follow-up modalities - To describe indications for biopsy, curettage or resection - To describe the level of pain and overall quality of life for patients with solitary chondroma as well as the impact of biopsy, curettage or resection -To describe the demographic, clinical, radiological, biological, molecular and genetic factors associated with, or predictive of, sarcomatous change. - To describe the demographic, clinical, radiological, biological, molecular and genetic factors predicting change (improvement or deterioration) in the overall quality of life and level of pain in patients with solitary chondroma - To evaluate the iatrogenic risks of biopsy, curettage or resection of solitary chondroma |
| Inclusion criteria | Inclusion criteria are: -Patients over 18 years of age -Patients with a single cartilaginous non-operative tumour -Patients fulfilling radiographic, scintigraphic, CT and/or MRI criteria for solitary chondroma -Patients who agreed to participate in the study and proposed follow-up and who have signed the informed consent for biocollection. |
| 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 |
National |
| Detail of the geography area | 12 participating research centres (RESOS Network) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/2015 |
| Date of last collection (YYYY or MM/YYYY) | 2030 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 200 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Paraclinical data (detail) | Radiology |
| Biological data (detail) | Tissue, serum, DNA |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Tissues DNA |
| Details of biobank content | Sample freezing will be carried out for storage at -80°C. Freezing multiple small quantities (a few milligrams) is preferred. Blood samples will be delivered and stored in biological resource centres and/or tumour banks and/or research units associated with the involved sites to undergo initial treatment for conservation. |
| 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 | Follow-up over 10 years |
| 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 |
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