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

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ClinicalTrials.gov Identifier: NCT03471468
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Gastric Cancer Procedure: kinetics of microparticles under chemotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of the Kinetics of Microparticles Under Chemotherapy in Patients With Gastric or Pancreatic Cancer
Actual Study Start Date : July 23, 2018
Estimated Primary Completion Date : November 2, 2019
Estimated Study Completion Date : July 2, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. incidence of thrombosis during study [ Time Frame: Before chemotherapies #1 to #6 and one year after inclusion. ]
    Deep vein thrombosis or pulmonary embolism

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471468


Contacts
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Contact: Rafik Belhadj Chaidi +33549444422 rafik.belhadj-chaidi@chu-poitiers.fr

Locations
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France
CHU of Poitiers Recruiting
Poitiers, France, 86000
Contact: Rafik Belhadj Chaidi, MD         
Principal Investigator: Rafik Belhadj Chaidi, MD         
Sponsors and Collaborators
Poitiers University Hospital

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03471468     History of Changes
Other Study ID Numbers: DOMICA
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Poitiers University Hospital:
Microparticles
Pancreatic cancer
Gastric cancer
Chemotherapy
Venous thromboembolism
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Stomach Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases