Myeloproliferative DisorderBioScoreSMPNCT03869476
Pilot Study for the Development of a Diagnostic Score to Differentiate Myeloproliferative Neoplasms.
A study testing Non-invasive diagnosis score in people with Myeloproliferative Disorder and Essential Thrombocythemia, run by University Hospital, Angers at 2 sites in France.
Trial summary
Prospective study for the development of a non-invasive score for differentiating prefibrotic myelofibrosis from essential thrombocytosis and overt myelofibrosis. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Myeloproliferative Disorder, Essential Thrombocythemia, Primary Myelofibrosis, Prefibrotic Stage
- What is being tested?
- Non-invasive diagnosis score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Jul 2019to 30 Jan 2024
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18 years of age or older) with the diagnosis of essential thrombocytosis, prefibrotic myelofibrosis or overt myelofibrosis according to WHO 2016 criteria;
- Patient who has not received specific treatment for neoplasms;
- Patient who has signed the consent to participate in the study;
- Patient who has consented to be included in the "Malignant Haemopathies" collection at the University Hospital of Angers or Brest and for whom the samples necessary for the study are available in the biocollection.
Who cannot join
- Patient with another hematologic neoplasm or progressive cancer at the time of diagnosis;
- Patient with a diagnosis of secondary myelofibrosis;
- Pregnant or breastfeeding woman;
- Person prived of liberty by judicial or administrative decision;
- Person subject to a legal protection measure;
Trial locations and contacts
2 sites in 1 country.
France2 sites
Chu Angers
Angers, 49000
CHRU de Brest - Hôpital Morvan
Brest, 29100
About this study
Official title: Pilot Study for the Development of a Non-invasive Diagnostic Score to Differentiate Between Essential Thrombocythemia, Premyelofibrosis and Myelofibrosis
Prospective study for the development of a non-invasive score for differentiating prefibrotic myelofibrosis from essential thrombocytosis and overt myelofibrosis.
Read the detailed description
The diagnostic criteria for myeloproliferative neoplasia have recently been revised in the WHO 2016 classification, which now recognizes a new entity between essential thrombocythemia (TE) and overt myelofibrosis (or primary myelofibrosis): prefibrotic myelofibrosis. Prefibrotic myelofibrosis patients seem to have a poorer prognosis compared to essential thrombocythemia in term of overall survival and myelofibrotic evolution. The dichotomy between these diseases is based on the bone marrow biopsy evaluation and is challenging with a lack of reproducibility showed in the literature.
This study aims to develop a diagnostic non-invasive score for differentiating prefibrotic myelofibrosis from essential thrombocytosis and overt myelofibrosis.
The parameters studied are :
- spleen fibrosis by elastography
- plasma cytokines levels
- mutationnal landscape by NGS
- CD34 circulating cells
Bone marrow biopsy were reviewed by 2 anatomopathologists. Number of patients to be enrolled : 130
- Conditions
- Myeloproliferative Disorder, Essential Thrombocythemia, Primary Myelofibrosis, Prefibrotic Stage, Primary Myelofibrosis, Fibrotic Stage
- Being tested
- Non-invasive diagnosis score
- Medical subject headings
- Myeloproliferative Disorders, Thrombocythemia, Essential, Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive diagnosis scoreDiagnostic test
- spleen fibrosis by elastography
- plasma cytokines levels
- mutationnal landscape by NGS
- CD34 circulating cells
| Study group | Role | What they receive |
|---|---|---|
| BioscoreSMP cohort | Experimental | Not described Receives: Diagnostic Test: Non-invasive diagnosis score |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHO 2016 criteria for prefibrotic myelofibrosis, essential thrombocytosis and overt myelofibrosis diagnosis
Assessment of the non-invasive diagnostic score against the WHO diagnosis
Measured: At the time of diagnosis : disease classification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start30 Jul 2019
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative DisorderStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869476
- Sponsor's protocol ID
- 49RC18_0153_1
- Acronym
- BioScoreSMP
- Status last verified
- Dec 2024
- First submitted
- 6 Mar 2019
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data of study protocol, Statiscal analysis plan and the infromed consent form will be made available after the study completion
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Development of a Non-invasive Diagnostic Score to Differentiate Between Essential Thrombocythemia, Premyelofibrosis and Myelofibrosis
- ClinicalTrials.gov ID
- NCT03869476
- Acronym / sponsor ID
- BioScoreSMP / 49RC18_0153_1
- Conditions
- Myeloproliferative Disorder, Essential Thrombocythemia, Primary Myelofibrosis, Prefibrotic Stage, Primary Myelofibrosis, Fibrotic Stage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 11 Mar 2019 (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.
Prospective study for the development of a non-invasive score for differentiating prefibrotic myelofibrosis from essential thrombocytosis and overt myelofibrosis.
Detailed description
The diagnostic criteria for myeloproliferative neoplasia have recently been revised in the WHO 2016 classification, which now recognizes a new entity between essential thrombocythemia (TE) and overt myelofibrosis (or primary myelofibrosis): prefibrotic myelofibrosis. Prefibrotic myelofibrosis patients seem to have a poorer prognosis compared to essential thrombocythemia in term of overall survival and myelofibrotic evolution. The dichotomy between these diseases is based on the bone marrow biopsy evaluation and is challenging with a lack of reproducibility showed in the literature.
This study aims to develop a diagnostic non-invasive score for differentiating prefibrotic myelofibrosis from essential thrombocytosis and overt myelofibrosis.
The parameters studied are :
- spleen fibrosis by elastography
- plasma cytokines levels
- mutationnal landscape by NGS
- CD34 circulating cells
Bone marrow biopsy were reviewed by 2 anatomopathologists. Number of patients to be enrolled : 130
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioscoreSMP cohort | Experimental | Diagnostic Test: Non-invasive diagnosis score |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (18 years of age or older) with the diagnosis of essential thrombocytosis, prefibrotic myelofibrosis or overt myelofibrosis according to WHO 2016 criteria;
- Patient who has not received specific treatment for neoplasms;
- Patient who has signed the consent to participate in the study;
- Patient who has consented to be included in the "Malignant Haemopathies" collection at the University Hospital of Angers or Brest and for whom the samples necessary for the study are available in the biocollection.
Key exclusion criteria (5 listed)
- Patient with another hematologic neoplasm or progressive cancer at the time of diagnosis;
- Patient with a diagnosis of secondary myelofibrosis;
- Pregnant or breastfeeding woman;
- Person prived of liberty by judicial or administrative decision;
- Person subject to a legal protection measure;
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 |
|---|---|---|
| Non-invasive diagnosis score* spleen fibrosis by elastography * plasma cytokines levels * mutationnal landscape by NGS * CD34 circulating cells | Diagnostic test | BioscoreSMP cohort |
Primary outcome
WHO 2016 criteria for prefibrotic myelofibrosis, essential thrombocytosis and overt myelofibrosis diagnosis
Time frame: At the time of diagnosis : disease classification
Assessment of the non-invasive diagnostic score against the WHO diagnosis
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 30 Dec 2024.
- Individual participant dataSharing planned: Yes. Data of study protocol, Statiscal analysis plan and the infromed consent form will be made available after the study completion
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive diagnosis score in people with Myeloproliferative Disorder and Essential Thrombocythemia, run by University Hospital, Angers at 2 sites 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 4 inclusion and 5 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 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
WHO 2016 criteria for prefibrotic myelofibrosis, essential thrombocytosis and overt myelofibrosis diagnosis (time frame: At the time of diagnosis : disease classification). 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 30 Dec 2024.