Myelodysplastic Syndrome (MDS)MYRIFICNCT02905552
Myelodysplasic Syndromes and Risk Factors for Infection
An observational study of Myelodysplastic Syndrome (MDS) and Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Myelodysplastic Syndromes (MDS) are characterized by quantitative and qualitative bone marrow failure and by a disorder of the medullary production which is a pre-leukemic state which can evolve into acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome (MDS), Infection, Risk Factors
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Sep 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with high-risk MDS (IPSS > 1,5)
Who may be able to join
- Age > 18 years old
- MDS with IPSS >1.5
- With a first infectious episode since the diagnosis of SMD of high risk (Case)
- Unhurt of any infection and being able to be mated in the case index (Control)
- Consulting or hospitalized in one of the services involved in the study during the period of inclusion
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Andrea Toma, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
Henri Mondor Hospital
Créteil, 94010
Laetitia Grégoire, 01 49 81 41 64, Laetitia.gregoire@aphp.fr
About this study
Official title: Myelodysplasic Syndromes and Risk Factors for Infection : A Case / Control Study
Myelodysplastic Syndromes (MDS) are characterized by quantitative and qualitative bone marrow failure and by a disorder of the medullary production which is a pre-leukemic state which can evolve into acute myeloid leukemia.
The risk of leukemic transformation is estimated by the score IPSS (International Prognostic Score System). We distinguish the MDS of low risk (IPSS<1) and those of high risk of leukemic transformation (IPSS=1,5).
Read more
Besides the risk of leukemic transformation, MDS much be complicated of infections which could be life-threatening.
The risk of developing first infection after the diagnosis of MDS of high risk is probably influenced by anamnestic (disease duration, comorbidities), clinical (veinous central catheter, previous hospitalization), biological (neutropenia, lymphopenia, serum ferritin) and therapeutics (demethylating agent, lenalidomide, erythropoietin, G-CSF, transfusions, anti-infectious preventive treatment) factors. Their identification will allow for improved targeting of the population which is is likely to benefit from anti-infective prophylaxis Primary objective is to identify risk factors associated with first acute episode of infection in patients with MDS, by comparing index cases and matched control cases who did not develop infection episode since diagnosis.
Secondary objectives are to explore nature and severity of infectious episodes, number of recurrences during 1 year of follow up and survival at 6 and 12 months
Read the detailed description
- 160 couples (Case / Control)
- Pairing according to age (+/- 5 years), sex and medical consultation date (+/-15 days)
- Follow up at M3, M6, M9 and M12
- Study duration : 24 months
- Inclusion duration : 12 months
- Being tested
- No intervention
- Keywords
- Myelodysplastic syndrome (myelodysplasia), Infection, Risk Factors
- Medical subject headings
- Myelodysplastic Syndromes, Infections, Anemia, Refractory, with Excess of Blasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Case group | Patient developing a first episode of infection since diagnosis of high-risk MDS (index case) Receives: Other: No intervention | |
| Control group | Patient with no infection since diagnosis of MDS
Patient will be paired to index case by:
* Hospital site
* Age
* Sexe Control patient is eligible if he has been seen in consultation within 15days before or after date of first infection of index case If matching fails, control patient can be found in another site and/or within 30days before or after date of first infection of index case Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of infectious episode
Measured: 12 months follow-up
Secondary outcomes (2)
severity of infectious episode
Measured: 12 months follow-up
Overall Survival (all-cause mortality)
Measured: 12months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic Syndrome (MDS)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Toma, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905552
- Sponsor's protocol ID
- NI13004
- Acronym
- MYRIFIC
- Status last verified
- Dec 2016
- First submitted
- 14 Sep 2016
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myelodysplasic Syndromes and Risk Factors for Infection : A Case / Control Study
- ClinicalTrials.gov ID
- NCT02905552
- Acronym / sponsor ID
- MYRIFIC / NI13004
- Keywords
- Myelodysplastic syndrome (myelodysplasia), Infection, Risk Factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 19 Sep 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.
Myelodysplastic Syndromes (MDS) are characterized by quantitative and qualitative bone marrow failure and by a disorder of the medullary production which is a pre-leukemic state which can evolve into acute myeloid leukemia.
The risk of leukemic transformation is estimated by the score IPSS (International Prognostic Score System). We distinguish the MDS of low risk (IPSS<1) and those of high risk of leukemic transformation (IPSS=1,5).
Besides the risk of leukemic transformation, MDS much be complicated of infections which could be life-threatening.
The risk of developing first infection after the diagnosis of MDS of high risk is probably influenced by anamnestic (disease duration, comorbidities), clinical (veinous central catheter, previous hospitalization), biological (neutropenia, lymphopenia, serum ferritin) and therapeutics (demethylating agent, lenalidomide, erythropoietin, G-CSF, transfusions, anti-infectious preventive treatment) factors. Their identification will allow for improved targeting of the population which is is likely to benefit from anti-infective prophylaxis Primary objective is to identify risk factors associated with first acute episode of infection in patients with MDS, by comparing index cases and matched control cases who did not develop infection episode since diagnosis.
Secondary objectives are to explore nature and severity of infectious episodes, number of recurrences during 1 year of follow up and survival at 6 and 12 months
Detailed description
- 160 couples (Case / Control)
- Pairing according to age (+/- 5 years), sex and medical consultation date (+/-15 days)
- Follow up at M3, M6, M9 and M12
- Study duration : 24 months
- Inclusion duration : 12 months
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: No interventionPatient developing a first episode of infection since diagnosis of high-risk MDS (index case) |
| Control group | – | Other: No interventionPatient with no infection since diagnosis of MDS Patient will be paired to index case by: * Hospital site * Age * Sexe Control patient is eligible if he has been seen in consultation within 15days before or after date of first infection of index case If matching fails, control patient can be found in another site and/or within 30days before or after date of first infection of index case |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high-risk MDS (IPSS > 1,5)
Key inclusion criteria (5 listed)
- Age > 18 years old
- MDS with IPSS >1.5
- With a first infectious episode since the diagnosis of SMD of high risk (Case)
- Unhurt of any infection and being able to be mated in the case index (Control)
- Consulting or hospitalized in one of the services involved in the study during the period of inclusion
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| No intervention | Other | Case group, Control group |
Primary outcome
Occurrence of infectious episode
Time frame: 12 months follow-up
2 secondary outcomes
severity of infectious episode
Time frame: 12 months follow-up
Overall Survival (all-cause mortality)
Time frame: 12months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 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.
Andrea Toma, MD, PhD contact
Andrea Toma, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Myelodysplastic Syndrome (MDS) and Infection, run by Assistance Publique - Hôpitaux de Paris 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 1 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: status not confirmed, as of the sponsor's last update on 21 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Toma, MD, PhD (andrea.toma@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of infectious episode (time frame: 12 months follow-up). 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 21 Dec 2016.