Last update : 06/18/2014 | Version : 1 | ID : 60160
| General | |
| Identification | |
| Detailed name | Analysis of the genetic expression contribution towards the development of metastases in colon cancer patients with no lymph node involvement | 
| Sign or acronym | ICOMET | 
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | no. iCOMET/IPC 2009-002. Avis CCTIRS et CPP | 
| General Aspects | |
| Medical area | Cancer research | 
| Health determinants | Genetic | 
| Others (details) | Colon cancer with no lymph node involvement | 
| Keywords | Health episodes, onset, metastases | 
| Scientific investigator(s) (Contact) | |
| Name of the director | Olschwang | 
| Surname | Sylviane | 
| Address | 13009 MARSEILLE | 
| Phone | + 33 (0)4 91 22 34 06 | 
| sylviane.olschwang@inserm.fr | |
| Unit | CENTRE DE RECHERCHE EN CANCÉROLOGIE DE MARSEILLE UMR891 INSERM | 
| Organization | INSERM | 
| Name of the director | Saurin | 
| Address | 69003 LYON | 
| Phone | + 33 (0)4 78 86 16 89 | 
| jean-christophe.saurin@chu-lyon.fr | |
| Unit | CELLULES ENDOCRINES ET DIGESTIVES NORMALES ET NÉOPLASIQUES U865 INSERM | 
| Organization | INSERM | 
| Collaborations | |
| Participation in projects, networks and consortia | Yes | 
| Funding | |
| Funding status | Private | 
| Details | ASSOCIATION POUR LE RECHERCHE CONTRE LE CANCER (ARC) LABORATOIRE SERVIER INTERNATIONAL | 
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CLCC INSTITUT PAOLI-CALMETTES | 
| 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. | Prospective Inclusion cut-off date: 01/08/2013 Patients with colon cancer, 1/3 having metastases at follow-up, 2/3 living without metastases at follow-up | 
| Database objective | |
| Main objective | General objective: to analyse genetic expression contribution towards the development of metastases Secondary objective: to analyse genetic expression contribution towards histologic and genetic types of colon cancer | 
| Inclusion criteria | Adults with sporadic colon cancer | 
| Population type | |
| Age | Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) | 
| Population covered | Sick population | 
| Gender | Male Woman | 
| Geography area | National | 
| Detail of the geography area | Multicentric cohort throughout France (40 centres): | 
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 09/2009 | 
| Date of last collection (YYYY or MM/YYYY) | 02/2019 | 
| Size of the database | |
| Size of the database (number of individuals) | [1000-10 000[ individuals | 
| Details of the number of individuals | 7800 | 
| Data | |
| Database activity | Current data collection | 
| Type of data collected | Clinical data Biological data | 
| Clinical data (detail) | Direct physical measures Medical registration | 
| Biological data (detail) | Type of samples taken: Blood and fixed tissue | 
| Presence of a biobank | Yes | 
| Contents of biobank | Tissues DNA | 
| Details of biobank content | DNA bank, tumour bank | 
| Health parameters studied | Health event/morbidity Health event/mortality | 
| Procedures | |
| Data collection method | Clinical examinations: direct input Biological analysis: direct input | 
| Participant monitoring | Yes | 
| Details on monitoring of participants | Follow-up duration: 54 months | 
| Links to administrative sources | No | 
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may be used by academic teams Access subject to favourable opinion of the scientific committee Raw clinical and biological database available Biological specimen aliquots for target characterisation available - To be decided if data may be used by industrial teams | 
| Access to aggregated data | Access on specific project only | 
| Access to individual data | Access on specific project only | 
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