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

Pancreatic Cancer Clinical Trial

— DOMICA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03471468
• Other study ID #: DOMICA
• Status: Terminated
• Phase: N/A
• Start date: July 23, 2018
• Est. completion date: January 2, 2020

Study information

• Verified date: February 2020
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 2, 2020
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Stomach Neoplasms

Intervention

Procedure:
• kinetics of microparticles under chemotherapy
Blood samples done before chemotherapy and 6 hours later for each of six chemotherapies required by the protocol.

Locations

Country	Name	City	State
France	CHU of Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	incidence of thrombosis during study	Deep vein thrombosis or pulmonary embolism	Before chemotherapies #1 to #6 and one year after inclusion.
Secondary	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