ITMO public health
Last update : 10/25/2016 | Version : 1 | ID : 73329
| General | |
| Identification | |
| Detailed name | Observational, retrospective study exploring RAS mutation tests practices in patients with metastatic colorectal cancer in 2014 |
| Sign or acronym | Flash-RAS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n°1748157 |
| General Aspects | |
| Medical area |
Anatomy - Cytology Biology Cancer research |
| Pathology (details) | Colorectal cancer |
| Health determinants |
Healthcare system and access to health care services |
| Keywords | RAS mutation tests, Colorectal cancer |
| Scientific investigator(s) (Contact) | |
| Name of the director | ARTRU |
| Surname | Pascal, MD |
| Unit | Gastroenterology, Hepatology and Gastrointestinal Oncology Department, Hôpital Jean Mermoz, lyon, France |
| Name of the director | DUCREUX |
| Surname | Michel, Prof |
| Unit | Gastroenterology Unit, Gustave Roussy, Villejuif, France |
| Name of the director | LAURENT-PUIG |
| Surname | Pierre, Prof |
| Unit | Biochemistry Department, HEGP, Paris, France |
| Name of the director | LIEVRE |
| Surname | Astrid, MD |
| Unit | Gastroenterology Department, Pontchaillou University hospital, Rennes, France |
| Name of the director | MERLIN |
| Surname | Jean Louis, Prof |
| Unit | Biopathology department, Institut de Cancérologie de Lorraine, Nancy, France |
| Name of the director | SABOURIN |
| Surname | Jean-Christophe, Prof |
| Unit | Pathology department, CHU Ch.Nicolle, Rouen, France |
| 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. | A list of hospital physicians (oncologists and gastroenterologists) treating patients with metastatic colorectal cancer in France, issued from the program of Medicalisation of data system (PMSI) and/or having taken part in the Flash-KRAS Study in 2011, were invited to participate in the study by letter or by telephone. |
| Database objective | |
| Main objective |
To assess the RAS (KRAS and NRAS exons 2,3 and 4) mutation screening test request and realisation rates in patients with a recent diagnosis of metastatic colorectal cancer.
Secondary objectives: - To describe changes in the KRAS (exon 2) mutation test request rate between 2011 and 2014; - To describe the reasons for requesting/not requesting and performing/not performing these tests as a function of physician and patient profiles - To describe and to analyse the impact of KRAS (exons 2,3 and 4) and NRAS (exons 2.3 and 4) results, the anatomopathology department availability to provide the tests, and the BRAF result, on therapeutic decision-making or changes in ongoing treatment; - To describe and analyse clinical characteristics of patients and treatments planned and received as first-line therapy of metastatic disease; - To describe the laboratory test method, the type of mutation request (if available) and the method and route by which the result was communicated to the physicians (result report); - To describe and to analyse the time to receipt the KRAS and NRAS results, the process (who ordered the test and when) and the therapeutic approach chosen during this period |
| Inclusion criteria |
To obtain the best possible representativeness while limiting bias, the physician had to screen consecutive patients followed for metastatic colorectal cancer and who had to satisfy the following criteria:
- patients 18 years of age or older, - patients with metastatic colorectal cancer histologically-confirmed after march 2014 (date the NRAS tests become available in French centers), - patients seen by the physician between June 15th , 2014 and September 30th, 2014 who have already started first-line treatment, during that time interval, for mCRC - patients in whom first-line therapy of metastatic disease had been already initiated between March 1st, 2014 and June 30th, 2014 - patients seen in a routine visit during the official 15-week screening period of 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 |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 15/06/2014 |
| Date of last collection (YYYY or MM/YYYY) | 30/09/2014 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | N= 375 patients, included by 104 physicians |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Biological data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | History of primary colorectal cancer; first-line therapy of metastatic disease; request for KRAS marker genotyping; impact of result on therapeutic management |
| Declarative data (detail) |
Paper self-questionnaire |
| Details of collected declarative data | Physician's demographic characteristics; data related to his/her practice; size of community of practice; date the NRAS test became available in the pathology/department center; demographic data on patients |
| Biological data (detail) | Waiting period for test result; genotyping test report |
| Presence of a biobank |
No |
| Health parameters studied |
Health care consumption and services |
| Procedures | |
| Data collection method | Data collected were obtained from the medical notes of patients seen at a visit during the study period (data already recorded), restrospectively with a paper questionnaire and the copy of the molecular biology report from which all reference to the patient by name had been removed to be anonymous |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | FLASH RAS poster Carrefour patho 2015 VF.pdf |
| Description | Carrefour pathologie, Novembre 2015 |
| Link to the document | FLASH RAS poster ISPOR 2015 VF.pdf |
| Description | ISPOR, Novembre 2015 |
| Link to the document | poster_FlashRAS_120x80cm_HD_stdc - JFHOD 2015- VF.pdf |
| Description | JFHOD 2015 |
| Link to the document | FLASH RAS communication orale PEP7 VF.pptx |
| Description | Communication orale, 7° colloque PEP 2015 |
| Link to the document | Poster ESMO.pdf |
| Description | ESMO, Septembre 2015 |
| Access | |
| Presence of document that lists variables and coding procedures |
No |
| Terms of data access (charter for data provision, format of data, availability delay) |
Methods of access are currently 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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