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

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ClinicalTrials.gov Identifier: NCT01907477
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : July 25, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Neutropenic Patients Other: Samples taken at the clinical hematology unit Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : August 2008
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
neutropenic patients Other: Samples taken at the clinical hematology unit



Primary Outcome Measures :
  1. the variability of protein profiles [ Time Frame: baseline ]


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907477


Locations
France
CHU de Dijon
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01907477     History of Changes
Other Study ID Numbers: Dalle PHRC IR 2009
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: July 25, 2013
Last Verified: July 2013