NCT02823132

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
Last Updated

July 6, 2016

Status Verified

June 1, 2016

First QC Date

June 29, 2016

Last Update Submit

July 5, 2016

Conditions

Acute LeukemiaInvasive Fungal Infection

Outcome Measures

Primary Outcomes (1)

  • serum level of Mannose Binding Lectin (MBL) in patients with acute leukemia

    1st day of the period of aplasia

Secondary Outcomes (1)

  • 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

Study Arms (2)

patients who develop a fungal infection

Biological: blood sample

patients without fungal infection

Biological: blood sample

Interventions

blood sampleBIOLOGICAL
patients who develop a fungal infectionpatients without fungal infection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with acute leukemia

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire

Dijon, 21079, France

Location

MeSH Terms

Conditions

Invasive Fungal Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 6, 2016

Primary Completion

June 1, 2015

Last Updated

July 6, 2016

Record last verified: 2016-06

Locations

FR(1)