Hematopoietic Cell ProliferationHEMASTEMNCT03107273
Development of an in Vitro Hematopoietic Culture System and Application to Myelodysplastic Syndromes.
An observational study of Hematopoietic Cell Proliferation and Myelodysplastic Syndromes, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Myelodysplastic syndromes (MDS) are myeloid hemopathies characterized by ineffective clonal haematopoiesis, peripheral cytopenias and a predisposition to the occurrence of acute myeloid leukemias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Cell Proliferation, Myelodysplastic Syndromes
- What is being tested?
- Dynamic cultures of in vitro hematopoietic stem cells
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2016to 23 Jan 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: Patient diagnosed with anemia and therefore the myelogram finds a low-risk myelodysplastic syndrome.
Who may be able to join
- Patient with diagnosis, major ≥18 years
- Explained in the blood disease department for cytopenia (s)
- For which diagnosis of myelodysplastic syndrome is considered
- Justifying a diagnostic bone marrow (myelogram)
- Having been informed of the progress of this study by the referring physician of the patient during the consultation and having expressed their non-opposition
Who cannot join
- High-grade myelodysplastic syndromes on IPSS score (intermediate -2 or more) on preliminary cytological analysis
- Acute mesoblastic leukemia from the outset
Trial locations and contacts
1 site in 1 country.
About this study
Myelodysplastic syndromes (MDS) are myeloid hemopathies characterized by ineffective clonal haematopoiesis, peripheral cytopenias and a predisposition to the occurrence of acute myeloid leukemias. Their diagnosis involves a cytological evaluation of the medulla, while their prognosis, in addition to extrinsic factors depending on the patient himself (age, comorbidities), intrinsic factors. The cytological evaluation is subject to a certain subjectivity since qualitative and the diagnosis is sometimes difficult in the absence of marker of clonality. More and more studies emphasize the interest of flow cytometry (CMF) in the diagnosis of SMD: by looking for qualitative and / or quantitative aberrations of the expression of membrane markers, CMF allows to establish scores Diagnosis that we have put in place within the laboratory. However, these studies are based on a static model that studies the phenotypic characteristics of patients at a given time but does not really reflect ineffective hematopoiesis. A dynamic model for in vitro reproduction of hematopoiesis would be an innovative tool for the study of SMD. This project aims to develop and standardize a system of differentiation in liquid medium of hematopoietic stem cells (CSH) in mature cells by studying each stage of the differentiation in terms of proliferation, apoptosis and phenotypic expression. HSCs will be obtained by CD34 + sorting from the medullary sample at diagnosis: the investigator will study cell proliferation, apoptosis and the acquisition of surface markers, in order to identify the quantitative and qualitative abnormalities associated with the differentiation of haematopoietic progenitors Smart. This should make it possible to identify diagnostic and prognostic factors in terms of response to treatment, acutism and survival.
- Being tested
- Dynamic cultures of in vitro hematopoietic stem cells
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic cultures of in vitro hematopoietic stem cellsOther
Improvement of prognostic scores used in myelodysplastic syndromes by identifying by dynamic in vitro culture of hematopoietic stem cells dynamic factors, reflections of ineffective haematopoiesis
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic patient | Not described Receives: Other: Dynamic cultures of in vitro hematopoietic stem cells | |
| Control | Not described Receives: Other: Dynamic cultures of in vitro hematopoietic stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotypic aberration detectable in flow cytometry during in vitro erythroid differentiation of hematopoietic stem cells from patients with MDS
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start16 Jun 2016
- Primary completion23 Jan 2018
- Study completion23 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Cell ProliferationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107273
- Sponsor's protocol ID
- PI2015_843_0035
- Acronym
- HEMASTEM
- Status last verified
- Jan 2019
- First submitted
- 31 Mar 2017
- Last updated
- 23 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an in Vitro Hematopoietic Culture System and Application to Myelodysplastic Syndromes.
- ClinicalTrials.gov ID
- NCT03107273
- Acronym / sponsor ID
- HEMASTEM / PI2015_843_0035
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- 23 Jan 2018 (actual)
- Study completion
- 23 Jan 2018 (actual)
- First posted
- 11 Apr 2017 (actual)
- 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 myeloid hemopathies characterized by ineffective clonal haematopoiesis, peripheral cytopenias and a predisposition to the occurrence of acute myeloid leukemias. Their diagnosis involves a cytological evaluation of the medulla, while their prognosis, in addition to extrinsic factors depending on the patient himself (age, comorbidities), intrinsic factors. The cytological evaluation is subject to a certain subjectivity since qualitative and the diagnosis is sometimes difficult in the absence of marker of clonality. More and more studies emphasize the interest of flow cytometry (CMF) in the diagnosis of SMD: by looking for qualitative and / or quantitative aberrations of the expression of membrane markers, CMF allows to establish scores Diagnosis that we have put in place within the laboratory. However, these studies are based on a static model that studies the phenotypic characteristics of patients at a given time but does not really reflect ineffective hematopoiesis. A dynamic model for in vitro reproduction of hematopoiesis would be an innovative tool for the study of SMD. This project aims to develop and standardize a system of differentiation in liquid medium of hematopoietic stem cells (CSH) in mature cells by studying each stage of the differentiation in terms of proliferation, apoptosis and phenotypic expression. HSCs will be obtained by CD34 + sorting from the medullary sample at diagnosis: the investigator will study cell proliferation, apoptosis and the acquisition of surface markers, in order to identify the quantitative and qualitative abnormalities associated with the differentiation of haematopoietic progenitors Smart. This should make it possible to identify diagnostic and prognostic factors in terms of response to treatment, acutism and survival.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnostic patient | – | Other: Dynamic cultures of in vitro hematopoietic stem cells |
| Control | – | Other: Dynamic cultures of in vitro hematopoietic stem cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient diagnosed with anemia and therefore the myelogram finds a low-risk myelodysplastic syndrome.
Key inclusion criteria (5 listed)
- Patient with diagnosis, major ≥18 years
- Explained in the blood disease department for cytopenia (s)
- For which diagnosis of myelodysplastic syndrome is considered
- Justifying a diagnostic bone marrow (myelogram)
- Having been informed of the progress of this study by the referring physician of the patient during the consultation and having expressed their non-opposition
Key exclusion criteria (2 listed)
- High-grade myelodysplastic syndromes on IPSS score (intermediate -2 or more) on preliminary cytological analysis
- Acute mesoblastic leukemia from the outset
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 |
|---|---|---|
| Dynamic cultures of in vitro hematopoietic stem cellsImprovement of prognostic scores used in myelodysplastic syndromes by identifying by dynamic in vitro culture of hematopoietic stem cells dynamic factors, reflections of ineffective haematopoiesis | Other | Control, Diagnostic patient |
Primary outcome
Phenotypic aberration detectable in flow cytometry during in vitro erythroid differentiation of hematopoietic stem cells from patients with MDS
Time frame: 1 day
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 23 Jan 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?
An observational study of Hematopoietic Cell Proliferation and Myelodysplastic Syndromes, run by Centre Hospitalier Universitaire, Amiens 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 2 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 23 Jan 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?
Phenotypic aberration detectable in flow cytometry during in vitro erythroid differentiation of hematopoietic stem cells from patients with MDS (time frame: 1 day). 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 23 Jan 2019.