Kinetics of Microparticles Under Chemotherapy in Patients With Gastric or Pancreatic Cancer

Poitiers University Hospital3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer Gastric Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Microparticles level will be assessed by automated and standardised measure of their procoagulant power using Kit STA©Procoag-PPL (Diagnostica Stago, Asnière, France)

Time frame: Before chemotherapies #1 to #6

Microparticles level will be assessed by automated and standardised measure of their procoagulant power using Kit STA©Procoag-PPL (Diagnostica Stago, Asnière, France)

Time frame: After 6 hours of chemotherapies #1 to #6

Secondary Outcomes

incidence of thrombosis during study

Deep vein thrombosis or pulmonary embolism

Time frame: Before chemotherapies #1 to #6 and one year after inclusion.

Khorana score does assess the risk of thrombosis uner chemotherapy according to 3 levels :Score 0, 1, 2 or 3

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.