ITMO public health
Last update : 10/18/2017 | Version : 1 | ID : 73327
| General | |
| Identification | |
| Detailed name | Retrospective observational study taking an inventory of the KRAS test in 2011 in patients with metastatic colorectal cancer having recently started a first-line treatment |
| Sign or acronym | Flash-KRAS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n°1474442 |
| General Aspects | |
| Medical area |
Anatomy - Cytology Biology Cancer research |
| Pathology (details) | Colorectal cancer |
| Health determinants |
Healthcare system and access to health care services |
| Keywords | Flash-KRAS, Colorectal cancer |
| Scientific investigator(s) (Contact) | |
| Name of the director | Dr ARTRU |
| Surname | Pascal |
| Unit | Department of Hepato-Gastroenterology and Digestive Oncology, Hôpital Jean Mermoz, Lyon |
| Name of the director | Pr DUCREUX |
| Surname | Michel |
| Unit | Gastroenterology Unit, IGR, Villejuif |
| Name of the director | Dr GUIU |
| Surname | Michel |
| Unit | Department of Anatomy and Pathology, Perpignan |
| Name of the director | Dr LAURENT-PUIG |
| Surname | Pierre |
| Unit | Department of Biochemistry, HEGP, Paris |
| Name of the director | Dr LIEVRE |
| Surname | Astrid |
| Unit | Department of Hepato-Gastroenterology and Digestive Oncology, Hôpital Ambroise Paré, Boulogne Billancourt |
| Name of the director | Pr MERLIN |
| Surname | Jean-Louis |
| Unit | Tumour Biology Unit, Centre Alexis Vautrin, Nancy |
| Name of the director | Pr SABOURIN |
| Surname | Jean-Christophe |
| Unit | Department of Anatomy and Pathological Cytology, CHU Ch.Nicolle, Rouen |
| Name of the director | Dr VIGUIER |
| Surname | Jerôme |
| Unit | Department of Gastroenterology and Hepatology, Hôpital Trousseau, Tours |
| Collaborations | |
| Participation in projects, networks and consortia |
No |
| Funding | |
| Funding status |
Private |
| Details | Merck |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Merck |
| Organisation status |
Private |
| Presence of scientific or steering committees |
Yes |
| Labelling and database evaluation | Scientific committee |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Retrospective, non-interventional pharmaco-epidemiological study. This study does not change the usual practices of the physician with respect to their patient. |
| Database objective | |
| Main objective |
Evaluate the KRAS test prescription rate in patients starting a first-line treatment for metastatic colorectal cancer.
Secondary objectives: - Describe the potential reasons for not prescribing this test - Describe and analyse the clinical characteristics of patients and treatments planned and received in first-line metastatic treatment - Describe and analyse the time frame for obtaining the result of the KRAS test and the channel (who makes the request and when) and the therapeutic attitude adopted during this period - Analyse the impact of the availability of the KRAS test and its result on the therapeutic choice of the physician - Describe the technic used for the analysis, the type of mutation (if available) and the method for reporting the results to the clinicians (report of the results) |
| Inclusion criteria |
Each participating centre had to select the exhaustiveness of the patients seen in consultation during the study period, meeting all of the following criteria:
- Patients aged 18 years or older, - Patients with histologically proven metastatic colorectal cancer, - Patients for whom a metastatic first-line treatment was initiated between 01/01/2011 and 27/03/2011, - Patients seen in consultation during the official 2-week study selection period. |
| 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 |
| Pathology | II - Neoplasms |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 28/03/2011 |
| Date of last collection (YYYY or MM/YYYY) | 08/04/2011 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | n=538 patients (160 centres) |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Biological data |
| Clinical data (detail) |
Direct physical measures |
| Details of collected clinical data | History of early colorectal cancer; First line metastatic treatment; Prescription of KRAS biomarker genotyping; impact of the result on therapeutic management |
| Declarative data (detail) |
Paper self-questionnaire |
| Details of collected declarative data | Demographic characteristics of the physician, data related to the medical practice, size of the town of the medical practice, physician’s thesis year / Patient’s demographics data |
| Biological data (detail) | Waiting period for KRAS test result; genotyping report |
| Presence of a biobank |
No |
| Health parameters studied |
Health care consumption and services |
| Procedures | |
| Data collection method | Medical records of patients seen during the study period retrospectively and using a paper questionnaire. Anonymised copy of the molecular biology report |
| Participant monitoring |
No |
| Followed pathology | |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | Lievre A et al. EJC Juin 2013.pdf |
| Link to the document | Poster KRAS ESMO version finale.pdf |
| Description | ESMO 2012 |
| Link to the document | poster Flash-KRAS JFHOD.pdf |
| Description | JFHOD 2012 |
| Access | |
| Presence of document that lists variables and coding procedures |
No |
| Terms of data access (charter for data provision, format of data, availability delay) |
Access terms and conditions are being defined
Contact: juliette.longin@merckgroup.com |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
No access |
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