ITMO public health
Last update : 08/17/2016 | Version : 1 | ID : 8883
| General | |
| Identification | |
| Detailed name | National Cohort of Secondary-Duct Intraductal Papillary Mucinous Neoplasms of the Pancreas |
| Sign or acronym | TEAM-P |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Endocrinology and metabolism Gastroenterology et hepatology |
| Keywords | intraductal papillary mucinous tumours of the pancreas; IPMN |
| Scientific investigator(s) (Contact) | |
| Name of the director | Rebours |
| Surname | Vinciane |
| Address | 100, boulevard du Général Leclerc 92110 Clichy |
| Phone | +33 (0)1 40 87 52 25 / +33 (0)1 40 87 52 25 |
| cohorteteamp@gmail.com / vinciane.rebours@bjn.aphp.fr | |
| Unit | Pancreatology Department, Beaujon Hospital |
| Organization | AP-HP (Paris Public Hospitals) |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | French National Society of Gastroenterology |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Société Nationale Française de Gastro-Entérologie |
| Organisation status |
Private |
| Sponsor(s) or organisation(s) responsible | Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux |
| Organisation status |
Private |
| Sponsor(s) or organisation(s) responsible | Club de Réflexion des Cabinets et Groupes d’Hépato-Gastroentérologie |
| Organisation status |
Private |
| Sponsor(s) or organisation(s) responsible | Société Française d'Endoscopie Digestive |
| Organisation status |
Private |
| Sponsor(s) or organisation(s) responsible | Club Francophone d'Echoendoscopie |
| Organisation status |
Private |
| Sponsor(s) or organisation(s) responsible | Club Français du Pancréas |
| Organisation status |
Private |
| Sponsor(s) or organisation(s) responsible | Société Française de Radiologie |
| Organisation status |
Private |
| 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 |
| Database objective | |
| Main objective |
To carry out a long-term standardised prospective study (over 5 years) of patients with IPMN in the secondary ducts that have not reached the main duct with no onset of deterioration.
The aims are to determine: – The risk of deterioration in the long term (main objective); – Morphological factors predicting deterioration (secondary aim) – Subgroups of patients at risk of deterioration based on their sociodemographic, clinical, morphological and molecular characteristics (secondary aim). |
| Inclusion criteria |
– IPMN only in the secondary ducts;
– No signs of malignant transformation of IPMN lesions; – Main pancreatic duct no more than 6 mm in diameter; – Presence of residual IPMN lesions in the secondary ducts for patients with a history of IPMN surgical resection. All patients with diagnosed secondary-duct IPMN before TEAM-P study was begun may be included. |
| 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 | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1,500 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Paraclinical data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | Morphological follow-up according to a unique standardised monitoring protocol for all patients. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | A file containing the sociodemographic and clinical characteristics of the patients will be completed at baseline by the physician on the dedicated website. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | – Prospective follow-up for a minimum period of 5 years from baseline, regardless of disease duration and monitoring; – Morphological study according to standardised monitoring protocol; – Centralised review of MRIs and scans by a group of radiology specialists. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Dedicated website | https://www.clininfohosting.com/specif/TEAMP/ |
| 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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