PiCADo - Longitudinal Study on "Domo-medicine" (Telemedicine) in Cancer Treatment
Head :
Levi Françis, INSERM UMRS776 "Rythmes Biologiques et Cancers" et
Unité de Chronothérapie, Département de Cancérologie
Last update : 07/01/2014 | Version : 1 | ID : 8119
| General | |
| Identification | |
| Detailed name | Longitudinal Study on "Domo-medicine" (Telemedicine) in Cancer Treatment |
| Sign or acronym | PiCADo |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL |
| General Aspects | |
| Medical area |
Cancer research |
| Health determinants |
Iatrogenic Nutrition |
| Keywords | Colon cancer, rectal cancer, pancreatic cancer, bronchopulmonary cancer, circadian rhythms, chrono-chemotherapy, Domo-medicine, lung cancer, Ile de France, Champagne-Ardenne |
| Scientific investigator(s) (Contact) | |
| Name of the director | Levi |
| Surname | Françis |
| Address | Hôpital Paul Brousse 14-16 avenue Paul Vaillant Couturier 94807 Villejuif Cedex (France) |
| Phone | +33 (0)1 45 59 35 95/38 55 |
| francis.levi@inserm.fr | |
| Unit |
INSERM UMRS776 "Rythmes Biologiques et Cancers" et Unité de Chronothérapie, Département de Cancérologie |
| Organization | Hôpital Paul Brousse - |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | Région Ile-de-France ainsi que par la Région Champagne-Ardenne |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM |
| 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 |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | The aim of PiCADo is to provide clinical, socio-economic and technological quantitative indicators with sufficient statistical reliability, so as to refine and validate early predictors of toxicity (asthenia, anorexia, diarrhoea, fever, neutropaenia) or indeed efficacy (tumour response, progression-free survival), to demonstrate a reduction in emergency admissions and severity of chemotherapy side effects compared to matched patients receiving similar treatment for the same condition under conventional conditions. |
| Inclusion criteria | - Men or women - Diagnosed with cancer (all cancer types) - Over 18 years of age - Treated as an outpatient - Living at home (alone or as a couple) - Covered by health insurance - Written consent in French to participate in the study |
| 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 |
Local |
| French regions covered by the database |
Alsace Champagne-Ardenne Lorraine Île-de-France |
| Detail of the geography area | Hôpital Paul Brousse (Villejuif) or Institut Jean Godinot (Reims). |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 04/2012 |
| Date of last collection (YYYY or MM/YYYY) | 2016 |
| 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 Biological data |
| Clinical data (detail) |
Medical registration |
| Biological data (detail) | Wireless physiological data sensors: scales (placed in the bathroom, bedroom or another room chosen by the patient), temperature, activity-rest and position sensor (worn continuously by the patient via a chest-level port system). |
| Presence of a biobank |
Yes |
| Contents of biobank |
Others |
| Details of biobank content | All collected data are securely stored (certified medical data hosting) in a central system constituting the patient record: - Data from the sensor and scales are transmitted via a portable data collector (Bluetooth Low Energy communication) - data from the collector and touch pad are transmitted to the patient's record via GPRS communication. |
| 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 | -- |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data is transmitted for 4 months on a daily basis from a mobile GPRS collector. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
