Acute LeukemiaMBL INFFONGNCT02823132
Study of the Level of a Protein Which Could Predict the Development of a Fungal Infection in Patients With Acute Leukemia
An observational study of Acute Leukemia and Invasive Fungal Infection, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Leukemia, Invasive Fungal Infection
- What is being tested?
- blood sample
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with acute leukemia
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Level of Mannose Binding Lectin (MBL) as a Predictor of the Onset of a Invasive Fungal Infection (IFI) During Chemo-induced Aplasia in Patients With Acute Leukemia (AL)
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.
- Conditions
- Acute Leukemia, Invasive Fungal Infection
- Being tested
- blood sample
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
| Study group | Role | What they receive |
|---|---|---|
| patients who develop a fungal infection | Not described Receives: Biological: blood sample | |
| patients without fungal infection | Not described Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum level of Mannose Binding Lectin (MBL) in patients with acute leukemia
Measured: 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
Measured: Every day except Saturday and Sunday for roughly 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Primary completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823132
- Sponsor's protocol ID
- Goyer APJ 2013
- Acronym
- MBL INFFONG
- Status last verified
- Jun 2016
- First submitted
- 29 Jun 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Level of Mannose Binding Lectin (MBL) as a Predictor of the Onset of a Invasive Fungal Infection (IFI) During Chemo-induced Aplasia in Patients With Acute Leukemia (AL)
- ClinicalTrials.gov ID
- NCT02823132
- Acronym / sponsor ID
- MBL INFFONG / Goyer APJ 2013
- Conditions
- Acute Leukemia, Invasive Fungal Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Primary completion
- Jun 2015 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who develop a fungal infection | – | Biological: blood sample |
| patients without fungal infection | – | Biological: blood sample |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with acute leukemia
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample | Biological | patients who develop a fungal infection, patients without fungal infection |
Primary outcome
serum level of Mannose Binding Lectin (MBL) in patients with acute leukemia
Time frame: 1st day of the period of aplasia
1 secondary outcome
Serum levels of MBL during an episode of aplasia for both groups of patients studied
Time frame: Every day except Saturday and Sunday for roughly 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukemia and Invasive Fungal Infection, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum level of Mannose Binding Lectin (MBL) in patients with acute leukemia (time frame: 1st day of the period of aplasia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.