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

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Neutropenic Patients

Treatments

Other: Samples taken at the clinical hematology unit

Study type

Interventional

Funder types

Other

Identifiers

NCT01907477
Dalle PHRC IR 2009

Details and patient eligibility

About

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.

Enrollment

500 patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

500 participants in 1 patient group

neutropenic patients
Other group
Treatment:
Other: Samples taken at the clinical hematology unit

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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