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

NCT ID: NCT03471468

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-23

Study Completion Date

2020-01-02

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.

Detailed Description

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Conditions

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Pancreatic Cancer Gastric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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kinetics of microparticles under chemotherapy

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

Group Type EXPERIMENTAL

kinetics of microparticles under chemotherapy

Intervention Type PROCEDURE

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

Interventions

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kinetics of microparticles under chemotherapy

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU of Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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DOMICA

Identifier Type: -

Identifier Source: org_study_id

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