ITMO public health
Last update : 08/17/2016 | Version : 1 | ID : 73194
| General | |
| Identification | |
| Detailed name | Cohort of Patients with Microscopic Colitis (Collagenous or Lymphocytic) |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Gastroenterology et hepatology |
| Pathology (details) | Microscopic colitis |
| Health determinants |
Genetic Lifestyle and behavior Social and psychosocial factors |
| Keywords | diarrhoea, intestinal disorder, colitis, cohort |
| Scientific investigator(s) (Contact) | |
| Name of the director | Macaigne |
| Surname | Gilles |
| Address | 2-4 cours de la Gondoire, 77 600 Jossigny, France |
| gmacaigne@ch-lagny77.fr | |
| Unit | Gastroenterology Department |
| Organization | Marne-la-Vallée Hospital |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Ferring Laboratory |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Marne-la-Vallée Hospital |
| 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 |
| Database objective | |
| Main objective | The aim is to describe the characteristics of a cohort of patients with microscopic colitis (MC; lymphocytic colitis (LC) or collagenous colitis (CC)) and to compare them with patients suffering from functional bowel disorders with diarrhoea. |
| Inclusion criteria |
Patients having at least three bowel movements daily with change in stool consistency;
Duration of illness for over 4 weeks; Normal or near-normal colonoscopy. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| 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) | 2010 |
| Date of last collection (YYYY or MM/YYYY) | 2012 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 433 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures |
| Details of collected clinical data | Personal history of appendectomy; cholecystectomy; BMI, number of daily bowel movements (3-4, 5-9, 10 or more); presence of nocturnal stools and abdominal pain. Date of diagnosis; smoking habits; weight loss. Medication. |
| Declarative data (detail) |
Paper self-questionnaire |
| Details of collected declarative data | Drug use. |
| Paraclinical data (detail) | Endoscopy and biopsies; histology |
| Biological data (detail) | C-reactive protein; serum potassium; haemoglobin; leukocytes and eosinophils; thyroid stimulating hormone. |
| Presence of a biobank |
Yes |
| Health parameters studied |
Health event/morbidity Health care consumption and services |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up during treatment after enrolment. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/25001258 |
| 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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