Gastric Cancer, Pancreatic Cancer
Conditions
Keywords
Microparticles, Pancreatic cancer, Gastric cancer, Chemotherapy, Venous thromboembolism
Brief summary
Microparticles have recently emerged as a thrombotic risk marker with a potential role in determining which patients are at greatest risk for developing thrombosis. Available data show an increase in the level of microparticles in cancer patients who are undergoing chemotherapy for solid tumors with a possible link to their thrombogenic state. Our study focuses on the kinetics of microparticles under chemotherapy in patients with pancreatic or gastric cancer by serial measurements of microparticles procoagulant activity. Detailed Description: The impact of chemotherapy on microparticles expression will be assessed by measuring their procoagulant activity on blood samples taken during the course of chemotherapy. The thrombotic risk will be evaluated by the score of Khorana in parallel. Microparticles expression in patients with thrombosis will be compared to that in other patients.
Interventions
PROCEDUREkinetics of microparticles under chemotherapy
Blood samples done before chemotherapy and 6 hours later for each of six chemotherapies required by the protocol.
Sponsors
Poitiers University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* First-line chemotherapy indicated and accepted by the patient for pancreatic cancer or gastric cancer * Confirmed diagnosis of pancreatic cancer or gastric cancer * Free subject, without guardianship or trusteeship or subordination * Patient benefiting from a social security scheme or benefiting through a third party * Consent given by the patient after clear and fair information about the study
Exclusion criteria
* Age \< 18yo * Life expectancy ≤10days * Deep vein thrombosis ou pulmonary embolism ≤3months * Patient unable to receive chemotherapy (sepsis, acute coronary syndrome, recent stroke, heparin-induced thrombocytopenia, disseminated intravascular coagulation) * Person enjoying enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergency situations * Pregnant or lactating woman and woman of childbearing age lacking effective contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Microparticles level will be assessed by automated and standardised measure of their procoagulant power using Kit STA©Procoag-PPL (Diagnostica Stago, Asnière, France) | Before chemotherapies #1 to #6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of thrombosis during study | Before chemotherapies #1 to #6 and one year after inclusion. | Deep vein thrombosis or pulmonary embolism |
| Khorana score does assess the risk of thrombosis uner chemotherapy according to 3 levels :Score 0, 1, 2 or 3 | Before chemotherapies #1 to #6 | Score 0= low risk (incidence of thrombosis = 0.3%) Score 1 or 2= intermediate risk (incidence of thrombosis = 2%) Score \>3 = high risk (incidence of thrombosis = 6.7%) The highest possible score is 6. |
Countries
France
Outcome results
None listed