CONNEXION CANCER - Risk score for venous thromboembolism
Head :
Leclerc-Zwirn Christel, Laboratoire GSK
Last update : 09/07/2020 | Version : 1 | ID : 150
| General | |
| Identification | |
| Detailed name | Risk score for venous thromboembolism |
| Sign or acronym | CONNEXION CANCER |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : AR 104238 |
| General Aspects | |
| Medical area |
Cancer research Cardiology |
| Health determinants |
Iatrogenic Medicine |
| Keywords | prospective cohort, risk score, oncology |
| Scientific investigator(s) (Contact) | |
| Name of the director | Leclerc-Zwirn |
| Surname | Christel |
| Phone | +33 (0)1 39 17 86 96 |
| christel.c.leclerc-zwirn@gsk.com | |
| Unit | Laboratoire GSK |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Laboratoire GSK |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Laboratoire GSK |
| 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 is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. |
The investigating doctors will propose the study to patients that meet the inclusion criteria during a normal visit in the department.
- Cohort of patients with a specific blood sample Doctors will present the objectives of the study and will explain the constraints linked to it (taking of an additional blood sample). The doctors will have patients who accept to participate in the study sign the consent agreement and will complete a prescription to request additional biological examinations for carrying out the dosage for the Tissue Factor, Thrombin Generation Time, Soluble P-selectin, D-dimers, Factor VIII and Fibrinogen which are not carried out in common medical practice. - Cohort of patients without a specific blood sample Doctors will present the objectives of the study and will give a specific information note to the patients. The protocol for the study does not require any visit or examination other than those performed in common practice. |
| Database objective | |
| Main objective | Develop a risk score of the appearance of venous thrombosis in patients with cancer, using clinical and biological parameters |
| Inclusion criteria |
• Patient aged 18 years or older
• Patient having: - Either metastatic cancer, regardless of its location (except for hematopoietic cancers), - Or one of the following cancers, at all stages of development: stomach, ovary, pancreas, lung, bladder, testicle • Patient: - For whom the cancer is currently being treated or - For whom the cancer treatment is scheduled or - Who do not have any cancer treatment in progress but who gave received a treatment (in the last 3 years) via chemotherapy or radiotherapy or hormone therapy or targeted therapies • In order to be included in the study, the subject for whom a search of additional biological parameters will be carried out must: - having given their free and informed consent in writing, - accept an additional blood sample be taken on the day of inclusion. |
| 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) | 2011 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 2500 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Biological data (detail) | • CBC (hemoglobin, platelets and white blood cells)• CRP• Plasma creatinine• Tissue Factor• Thrombin Generation Time• Soluble P-selectin• D-dimers• Factor VIII• Fibrinogen |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | A Clinical Study Technician (CST) will complete the observation logbook using the data collected in the medical dossier and will add the values of the biological parameters specifically dosed for the study using the results sent by the central laboratory. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | At 6 months: During a normally-scheduled follow-up visit 6 months after inclusion [tolerance of -7 days ; +21 days]. The doctor will validate with the patient if there was a venous thromboembolic event since inclusion. If such is the case, the doctor will note in the patient's medical dossier all of the elements making it possible to medically qualify the thromboembolic event, the date of occurrence and the treatments undertaken. The follow-up observation logbook will then be completed by the CST. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Publications |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
