Myeloproliferative NeoplasmOPIUMNCT06476535
Observatory of Patients With MyeloProliferative Neoplasm Treated With Anti-inflammatory Immunotherapy
An observational study of Myeloproliferative Neoplasm and Inflammatory Disease, run by University Hospital, Brest at 1 site in France.
Trial summary
The study will collect cases of MPN patients who also benefit from an anti-inflammatory immunotherapy for another disease. Efficacy and tolerability of the drug will be assessed in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm, Inflammatory Disease
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2024to 31 May 2026
- 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: MyeloProliferative Neoplasm patients followed in one of the centres participating to the FIM (French Intergroup- MPN) group
Who may be able to join
- MyeloProliferative Neoplasm diagnosis
- receiving or having received an immunotherapy targeting IL-1, IL-6, IL-17, IL-23 or TNF
Who cannot join
- Unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
The study will collect cases of MPN patients who also benefit from an anti-inflammatory immunotherapy for another disease. Efficacy and tolerability of the drug will be assessed in this population.
- Conditions
- Myeloproliferative Neoplasm, Inflammatory Disease
- Medical subject headings
- Myeloproliferative Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the anti-inflammatory immunotherapy
Depending on the indication of the anti-inflammatory treatment, clinical efficacy will be assessed clinically as number of patients reaching complete (total disappearance of initial symptoms- diarrhea, arthritis, fever, skin lesions), partial (improvement of symptoms, but not total disappearance) or absence of response (the treatment did not improve the symptoms). Clinical judgement will be according to the physician appreciation.
Measured: 1 year
Tolerability of the anti-inflammatory immunotherapy
Tolerability will be assessed as the number of reported unexpected side effects attributed to the treatment as judged by the caring physician, including treatment discontinuation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start11 Jun 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476535
- Sponsor's protocol ID
- 29BRC24.0155 - OPIUM
- Acronym
- OPIUM
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observatory of Patients With MyeloProliferative Neoplasm Treated With Anti-inflammatory Immunotherapy
- ClinicalTrials.gov ID
- NCT06476535
- Acronym / sponsor ID
- OPIUM / 29BRC24.0155 - OPIUM
- Conditions
- Myeloproliferative Neoplasm, Inflammatory Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 26 Jun 2024 (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.
The study will collect cases of MPN patients who also benefit from an anti-inflammatory immunotherapy for another disease. Efficacy and tolerability of the drug will be assessed in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MyeloProliferative Neoplasm patients followed in one of the centres participating to the FIM (French Intergroup- MPN) group
Key inclusion criteria (2 listed)
- MyeloProliferative Neoplasm diagnosis
- receiving or having received an immunotherapy targeting IL-1, IL-6, IL-17, IL-23 or TNF
Key exclusion criteria (1 listed)
- Unable to consent
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
Efficacy of the anti-inflammatory immunotherapy
Time frame: 1 year
Depending on the indication of the anti-inflammatory treatment, clinical efficacy will be assessed clinically as number of patients reaching complete (total disappearance of initial symptoms- diarrhea, arthritis, fever, skin lesions), partial (improvement of symptoms, but not total disappearance) or absence of response (the treatment did not improve the symptoms). Clinical judgement will be according to the physician appreciation.
Tolerability of the anti-inflammatory immunotherapy
Time frame: 1 year
Tolerability will be assessed as the number of reported unexpected side effects attributed to the treatment as judged by the caring physician, including treatment discontinuation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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 Myeloproliferative Neoplasm and Inflammatory Disease, run by University Hospital, Brest 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 2 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 26 Jun 2024. 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?
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?
Efficacy of the anti-inflammatory immunotherapy (time frame: 1 year). The study lists 2 primary outcomes in all. 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 26 Jun 2024.