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

Not Applicable

Terminated

• Conditions: Pancreatic Cancer; Gastric Cancer
• Interventions: Procedure: kinetics of microparticles under chemotherapy

• Registration Number: NCT03471468
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-12
• Study First Submitted QC: 2018-03-13
• Study First Posted: 2018-03-20
• Study Start: 2018-07-23
• Primary Completion: 2020-01-02
• Study Completion: 2020-01-02
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
kinetics of microparticles under chemotherapy	kinetics of microparticles under chemotherapy	kinetics of microparticles under chemotherapy in patients with pancreatic or gastric cancer by serial measurements of microparticles procoagulant activity.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
incidence of thrombosis during study	Before chemotherapies #1 to #6 and one year after inclusion.	Deep vein thrombosis or pulmonary embolism

Trial Locations

Locations (1)

CHU of Poitiers; 🇫🇷 Poitiers, France