Neutropenic PatientsNCT01907477
Identification of Serum and/or Plasma Biomarkers for the Diagnosis Prognosis and/or Prediction of Invasive Mycosis in Neutropenic Patients
A study testing Samples taken at the clinical hematology unit in people with Neutropenic Patients, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Neutropenic Patients
- What is being tested?
- Samples taken at the clinical hematology unit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2008to Nov 2012
- Phase
- Interventional
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- - 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Neutropenic Patients
- Being tested
- Samples taken at the clinical hematology unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samples taken at the clinical hematology unitOther
| Study group | Role | What they receive |
|---|---|---|
| neutropenic patients | Other | Not described Receives: Other: Samples taken at the clinical hematology unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
the variability of protein profiles
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startAug 2008
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neutropenic PatientsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 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
- NCT01907477
- Sponsor's protocol ID
- Dalle PHRC IR 2009
- Status last verified
- Jul 2013
- First submitted
- 17 Jul 2013
- Last updated
- 24 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Serum and/or Plasma Biomarkers for the Diagnosis Prognosis and/or Prediction of Invasive Mycosis in Neutropenic Patients
- ClinicalTrials.gov ID
- NCT01907477
- Acronym / sponsor ID
- Dalle PHRC IR 2009
- Conditions
- Neutropenic Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 25 Jul 2013 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neutropenic patients | Other | Other: Samples taken at the clinical hematology unit |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- - 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Samples taken at the clinical hematology unit | Other | neutropenic patients |
Primary outcome
the variability of protein profiles
Time frame: baseline
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 24 Jul 2019.
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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?
A study testing Samples taken at the clinical hematology unit in people with Neutropenic Patients, 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 4 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 24 Jul 2019. 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?
the variability of protein profiles (time frame: baseline). 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 24 Jul 2019.