Myeloproliferative NeoplasmsCTIM3NCT02823210
Clinical and Therapeutic Impact of Molecular Markers in Myeloproliferative Disorders
An observational study of Myeloproliferative Neoplasms, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Myeloproliferative neoplasms (MPN) are clonal hematopoietic disorders sharing a common natural evolution: a chronic phase, characterized by a major risk of vascular events, followed by an accelerated phase eventually leading to transformation to acute leukemia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myeloproliferative Neoplasms
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2016to Jun 2019
- 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: Philadelphia-negative Myeloproliferative neoplasms (MPN)
Who may be able to join
- Patients suffering from Myeloproliferative neoplasms (MPN) diagnosed between 2005 and 2013
- Sample DNA diagnostics available: 500 mcg
- Untreated or treated with hydroxyurea, ruxolitinib, alpha interferon,
- Patient has given his(her) own consent for the use of the sample for research on the pathology and genetic analyzes
Who cannot join
- Refused to participate
- Patient treated with another molecule that hydroxyurea, ruxolitinib, or alpha interferon
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Centre d'Investigations Cliniques
Paris, 75010
Jean-Jacques KILADJIAN, MDPhD, 33+1 42 49 94 94, jean-jacques.kiladjian@aphp.fr
- Recruiting
Centre d'Investigations Cliniques
Paris, 75010
Jean-Jacques KILADJIAN, 33+1 42 49 94 94, jean-jacques.kiladjian@sls.aphp.fr
About this study
Official title: Clinical and Therapeutic Impact of Molecular Markers in Myeloproliferative Neoplasms (CTIM3)
Myeloproliferative neoplasms (MPN) are clonal hematopoietic disorders sharing a common natural evolution: a chronic phase, characterized by a major risk of vascular events, followed by an accelerated phase eventually leading to transformation to acute leukemia. MPN include polycythemia vera, essential thrombocythemia, primary myelofibrosis, and rarer entities. During the past years, CML became a paradigm for targeted therapy and personalized cancer medicine. For other MPNs, the discovery of the JAK2V617F mutation followed by many other mutations, opened similar perspectives. However, several questions remain to be answered in MPNs regarding the clinical implication of these major scientific discoveries: what is the clinical impact of JAK2V617F and other molecular biomarkers on the risks of complications and progression? Can these new biomarkers be used in the perspective of a personalized therapy of MPNs? his project will focus on the qualification of a series of known mutations as biomarkers in MPNs based on large multicenter cohorts of patients with well-annotated samples
- Conditions
- Myeloproliferative Neoplasms
- Medical subject headings
- Myeloproliferative Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative incidence or progression
Measured: inclusion
Secondary outcomes (4)
Disease phenotype according to WHO classification
polycythemia vera, essential thrombocythemia, primary myelofibrosis, and others
Measured: 3 years
Treatment response/resistance
Measured: 3 years
Mean life-years gained
The analysis will take into consideration the cost of testing, but also the costs of different treatment options with or without testing, and other disease-related costs dependent on treatment
Measured: 3 years
Quality-adjusted life years gained
Measured: 3 years
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)
- Study startJun 2016
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmsStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823210
- Sponsor's protocol ID
- TRANSLA13-140
- Acronym
- CTIM3
- Status last verified
- Mar 2018
- First submitted
- 30 Jun 2016
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Therapeutic Impact of Molecular Markers in Myeloproliferative Neoplasms (CTIM3)
- ClinicalTrials.gov ID
- NCT02823210
- Acronym / sponsor ID
- CTIM3 / TRANSLA13-140
- Conditions
- Myeloproliferative Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- 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.
Myeloproliferative neoplasms (MPN) are clonal hematopoietic disorders sharing a common natural evolution: a chronic phase, characterized by a major risk of vascular events, followed by an accelerated phase eventually leading to transformation to acute leukemia. MPN include polycythemia vera, essential thrombocythemia, primary myelofibrosis, and rarer entities. During the past years, CML became a paradigm for targeted therapy and personalized cancer medicine. For other MPNs, the discovery of the JAK2V617F mutation followed by many other mutations, opened similar perspectives. However, several questions remain to be answered in MPNs regarding the clinical implication of these major scientific discoveries: what is the clinical impact of JAK2V617F and other molecular biomarkers on the risks of complications and progression? Can these new biomarkers be used in the perspective of a personalized therapy of MPNs? his project will focus on the qualification of a series of known mutations as biomarkers in MPNs based on large multicenter cohorts of patients with well-annotated samples
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Philadelphia-negative Myeloproliferative neoplasms (MPN)
Key inclusion criteria (4 listed)
- Patients suffering from Myeloproliferative neoplasms (MPN) diagnosed between 2005 and 2013
- Sample DNA diagnostics available: 500 mcg
- Untreated or treated with hydroxyurea, ruxolitinib, alpha interferon,
- Patient has given his(her) own consent for the use of the sample for research on the pathology and genetic analyzes
Key exclusion criteria (2 listed)
- Refused to participate
- Patient treated with another molecule that hydroxyurea, ruxolitinib, or alpha interferon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cumulative incidence or progression
Time frame: inclusion
4 secondary outcomes
Disease phenotype according to WHO classification
Time frame: 3 years
Treatment response/resistance
Time frame: 3 years
Mean life-years gained
Time frame: 3 years
Quality-adjusted life years gained
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Neoplasms, run by Assistance Publique - Hôpitaux de Paris 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 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: status not confirmed, as of the sponsor's last update on 29 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative incidence or progression (time frame: inclusion). 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 29 Mar 2018.