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

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Kinetics of Microparticles Under Chemotherapy in Patients With Gastric or Pancreatic Cancer

Conditions
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Gastric Cancer, Pancreatic Cancer

Intervention / Treatment
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* Procedure: kinetics of microparticles under chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: kinetics of microparticles under chemotherapy<br>kinetics of microparticles under chemotherapy in patients with pancreatic or gastric cancer by serial measurements of microparticles procoagulant activity. | Procedure: kinetics of microparticles under chemotherapy<br>* Blood samples done before chemotherapy and 6 hours later for each of six chemotherapies required by the protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| Microparticles level will be assessed by automated and standardised measure of their procoagulant power using Kit STA©Procoag-PPL (Diagnostica Stago, Asnière, France) |  | After 6 hours of chemotherapies #1 to #6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of thrombosis during study | Deep vein thrombosis or pulmonary embolism | 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. | Before chemotherapies #1 to #6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy, Microparticles, Pancreatic cancer, Gastric cancer, Venous thromboembolism