Clinical trial NCT03471468: Kinetics of Microparticles Under Chemotherapy in Patients With Gastric or Pancreatic Cancer
Official title: Study of the Kinetics of Microparticles Under Chemotherapy in Patients With Gastric or Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatic Cancer
Gastric Cancer
Keywords: Microparticles
Pancreatic cancer
Gastric cancer
Chemotherapy
Venous thromboembolism
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Microparticles level will be assessed by automated and standardised measure of their procoagulant power using Kit STA©Procoag-PPL (Diagnostica Stago, Asnière, France)
timeFrame: Before chemotherapies #1 to #6
measure: Microparticles level will be assessed by automated and standardised measure of their procoagulant power using Kit STA©Procoag-PPL (Diagnostica Stago, Asnière, France)
timeFrame: After 6 hours of chemotherapies #1 to #6
Secondary outcomes:
measure: incidence of thrombosis during study
timeFrame: Before chemotherapies #1 to #6 and one year after inclusion.
measure: Khorana score does assess the risk of thrombosis uner chemotherapy according to 3 levels :Score 0, 1, 2 or 3
timeFrame: Before chemotherapies #1 to #6
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU of Poitiers
Study officials:
References: