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

NCT ID: NCT01907477

Last Updated: 2019-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-11-30

Brief Summary

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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

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Conditions

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Neutropenic Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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neutropenic patients

Group Type OTHER

Samples taken at the clinical hematology unit

Intervention Type OTHER

Interventions

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Samples taken at the clinical hematology unit

Intervention Type OTHER

Eligibility Criteria

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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.

* Persons not covered by the national Health Insurance Agency

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).
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Dijon

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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Dalle PHRC IR 2009

Identifier Type: -

Identifier Source: org_study_id

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