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

February 12, 2020 updated by: Poitiers University Hospital

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France, 86000
        • CHU of POITIERS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: kinetics of microparticles under chemotherapy
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
Blood samples done before chemotherapy and 6 hours later for each of six chemotherapies required by the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome 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)
Time Frame: Before chemotherapies #1 to #6
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
After 6 hours of chemotherapies #1 to #6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of thrombosis during study
Time Frame: Before chemotherapies #1 to #6 and one year after inclusion.
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
Time Frame: 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.
Before chemotherapies #1 to #6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2018

Primary Completion (Actual)

January 2, 2020

Study Completion (Actual)

January 2, 2020

Study Registration Dates

First Submitted

February 12, 2018

First Submitted That Met QC Criteria

March 13, 2018

First Posted (Actual)

March 20, 2018

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOMICA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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