ITMO public health
Last update : 07/07/2015 | Version : 2 | ID : 60100
| General | |
| Identification | |
| Detailed name | Cohort of Patients with Melanoma |
| Sign or acronym | MELAN-COHORT |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL: 28/09/2005 |
| General Aspects | |
| Medical area |
Cancer research |
| Keywords | tumour, Health episodes, overall survival, disease-free survival |
| Scientific investigator(s) (Contact) | |
| Name of the director | Saiag |
| Surname | Philippe |
| Address | 92104 BOULOGNE CEDEX |
| Phone | + 33 (0)1 49 09 56 73 |
| Philippe.saiag@apr.aphp.fr | |
| Unit | EA 4339 PEAU CANCER ENVIRONNEMENT APHP, UVSQ |
| Organization | APHP |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Mixed |
| Details | SOCIETE FRANÇAISE DE DERMATOLOGIE, PHRC (MINISTERE DE LA SANTE), CANCEROPOLE IDF (INSTITUT NATIONAL DU CANCER + REGION ILE DE FRANCE), SOCIETE FRANÇAISE DE DERMATOLOGIE |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | APHP |
| 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. | Inclusion method: Prospective Inclusion cut-off date: 01/12/2008 |
| Database objective | |
| Main objective | General objective: to form the largest prospective cohort of melanoma patients in Europe with a blood and tissue biobank Secondary objective: to form a research team made up of clinicians, pathologists, geneticists and basic science researchers, in order to obtain high quality research responsiveness |
| Inclusion criteria | Inclusion criteria are: (i) histologically confirmed melanoma, (ii) recoverable primary cutaneous melanoma (iii) primary melanoma treated by surgical excision with a normal skin margin of at least 1 or 2 cm depending on thickness of melanoma (iv) at least 18 years of age (v) living in the Ile-de-France area, (vi) *Absence of other pathology affecting vital prognosis. Cohort inclusion date is uniform: within 3 months after surgical excision of primary melanoma; within 3 months of lymph node surgery in the case of lymph node extension, in one month following diagnosis of a transit metastasis or a distant metastasis. |
| 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 |
Regional |
| French regions covered by the database |
Île-de-France |
| Detail of the geography area | ILE DE FRANCE |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 09/2003 |
| Date of last collection (YYYY or MM/YYYY) | 12/2018 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1250 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Declarative data Paraclinical data Biological data |
| Declarative data (detail) |
Paper self-questionnaire |
| Paraclinical data (detail) | Imaging, anatomopathology |
| Biological data (detail) | Type of samples taken: Primary tumour, sentinel lymph node, other metastases. For blood: DNA, RNA, plasma, serum, PBMC, proteomics |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma DNA DNAc/RNAm |
| Details of biobank content | Serum bank, plasma bank, DNA bank, tumour bank, RNA. PBMC, PROTEOMICS |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Self-administered questionnaire: entry from a paper questionnaire (Manual input) Clinical examination: Handwritten (Manual input) Biological Analysis: Handwritten (Manual input) |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration: 10 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=melan-cohort+OR+melancohort |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may be used by academic teams Access conditions: on submission of project to steering committee, assessment of quantities consumed, establishment of a "Material Supply and Collaboration Agreement" if partner is outside of MELAN-COHORT Data may be use by industrial teams? Yes Access conditions: on submission of project to steering committee, assessment of quantities consumed, establishment of a "Material Supply and Collaboration Agreement" with the DRCD |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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