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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02823132
Other study ID # Goyer APJ 2013
Secondary ID
Status Completed
Phase N/A
First received June 29, 2016
Last updated July 5, 2016

Study information

Verified date June 2016
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Observational

Clinical Trial Summary

The aim of this study is to investigate levels of a protein, mannose binding lectin, in patients with acute leukemia who develop or not an invasive fungal infection.


Recruitment information / eligibility

Status Completed
Enrollment 134
Est. completion date
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria :

- persons who have provided written consent

- Patients with national health insurance cover

- Patients with malignant hemopathy who have been treated with chemotherapy able to induce profound neutropenia (PN < 500 / mm3) lasting more than 10 days.

- Patients with malignant hemopathy who have received an autologous bone marrow graft

- Patients with severe idiopathic medullar aplasia (PN < 500 / mm3) who need to be hospitalized for at least 10 consecutive days (with or without treatment with immunosuppressants)

Exclusion Criteria:

- Patients who have received an bone marrow PSC allograft (as such patients have a risk of aspergillosis, which appears in most cases after medullar recovery; they will not be included in the study).

- Patients who have received an autologous PSC graf (as the duration of neutropenia is in most cases less than 10 days).

- Patients whose neutropenia, retrospectively assessed, lasted less than 10 days.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Intervention

Biological:
blood sample


Locations

Country Name City State
France Centre Hospitalier Universitaire Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum level of Mannose Binding Lectin (MBL) in patients with acute leukemia 1st day of the period of aplasia No
Secondary Serum levels of MBL during an episode of aplasia for both groups of patients studied Every day except Saturday and Sunday for roughly 3 weeks No
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