Identification of Serum and/or Plasma Biomarkers for the Diagnosis Prognosis and/or Prediction of Invasive Mycosis in Neutropenic Patients

Not Applicable

Completed

• Conditions: Neutropenic Patients
• Interventions: Other: Samples taken at the clinical hematology unit

• Registration Number: NCT01907477
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

The aim of the present work is to study the protein expressions profiles of neutropenic patients (with a high risk of invasive mycosis) who developed - versus who did not develop invasive mycosis (principally aspergillosis and candidosis) in order to identify biomarkers for the diagnosis, prognosis and /or prediction of invasive mycosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-07
• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-07-22
• Study First Posted: 2013-07-25
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• • Patients with malignant haemopathy who received chemotherapy likely to lead to severe neutropenia (PN<500/mm3) for a foreseeable period of 10 days.
• Patients aged 14 years or older (no upper age limit)
• Patients with malignant haemopathy who received an autologous marrow graft.
• Patients with severe idiopathic medullar aplasia (PN<500/mm3) who need to be hospitalised for at least 10 days consecutively (with or without immunosuppressant treatment).
• Patients who have provided written informed consent to participate in this study.

Exclusion Criteria

• Patients who received an allograft of marrow or hematopoietic stem cell transplant (given that these patients carry a risk of aspergillosis, which in most cases appears after medullar recovery, they will not be included in the study).
• Patients who received an autologous hematopoietic stem cell transplant (given that the duration of the neutropenia is often less than 10 days).
• Patients who do not meet the inclusion criteria
• Persons not covered by the national Health Insurance Agency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neutropenic patients	Samples taken at the clinical hematology unit	-

Primary Outcome Measures

Name	Time	Method
the variability of protein profiles	baseline

Trial Locations

Locations (1)

CHU de Dijon; 🇫🇷 Dijon, France