NCT03471468

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable pancreatic-cancer

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

July 23, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

February 12, 2018

Last Update Submit

February 12, 2020

Conditions

Pancreatic CancerGastric Cancer

Keywords

MicroparticlesPancreatic cancerGastric cancerChemotherapyVenous thromboembolism

Outcome Measures

Primary Outcomes (2)

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

    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)

    After 6 hours of chemotherapies #1 to #6

Secondary Outcomes (2)

  • incidence of thrombosis during study

    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

    Before chemotherapies #1 to #6

Study Arms (1)

kinetics of microparticles under chemotherapy

EXPERIMENTAL

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

Interventions

kinetics of microparticles under chemotherapyPROCEDURE

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

kinetics of microparticles under chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU of Poitiers

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsStomach NeoplasmsVenous Thromboembolism

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesStomach DiseasesThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2018

First Posted

March 20, 2018

Study Start

July 23, 2018

Primary Completion

January 2, 2020

Study Completion

January 2, 2020

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)