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2018-07-23
2020-01-02
2020-01-02
3
NCT03471468
Poitiers University Hospital
Poitiers University Hospital
INTERVENTIONAL
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.
N/A
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-02-12 | N/A | 2020-02-12 |
2018-03-13 | N/A | 2020-02-17 |
2018-03-20 | N/A | 2020-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Basic Science
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
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
|
| Primary Outcome Measures | Measure Description | 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) | 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| incidence of thrombosis during study | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
