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Clinical Trials/NCT01907477
NCT01907477
Completed
Not Applicable

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

Centre Hospitalier Universitaire Dijon1 site in 1 country500 target enrollmentAugust 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neutropenic Patients
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
500
Locations
1
Primary Endpoint
the variability of protein profiles
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2008
End Date
November 2012
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

the variability of protein profiles

Time Frame: baseline

Study Sites (1)

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