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

Primary Purpose

Pancreatic Cancer, Gastric Cancer

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

kinetics of microparticles under chemotherapy

About this trial

This is an interventional basic science trial for Pancreatic Cancer focused on measuring Microparticles, Pancreatic cancer, Gastric cancer, Chemotherapy, Venous thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU of Poitiers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

kinetics of microparticles under chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

incidence of thrombosis during study

Deep vein thrombosis or pulmonary embolism

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.

Full Information

NCT ID

NCT03471468

First Posted

February 12, 2018

Last Updated

February 12, 2020

Sponsor

Poitiers University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03471468

Brief Title

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

Acronym

DOMICA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Terminated

Why Stopped

Low recruitment

Study Start Date

July 23, 2018 (Actual)

Primary Completion Date

January 2, 2020 (Actual)

Study Completion Date

January 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer, Gastric Cancer

Keywords

Microparticles, Pancreatic cancer, Gastric cancer, Chemotherapy, Venous thromboembolism

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

kinetics of microparticles under chemotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

kinetics of microparticles under chemotherapy

Intervention Description

Blood samples done before chemotherapy and 6 hours later for each of six chemotherapies required by the protocol.

Primary Outcome Measure Information:

Title

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

Title

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 Outcome Measure Information:

Title

incidence of thrombosis during study

Description

Deep vein thrombosis or pulmonary embolism

Time Frame

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

Title

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

Description

Time Frame

Before chemotherapies #1 to #6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

CHU of Poitiers

City

Poitiers

ZIP/Postal Code

86000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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