Observatory of Patients With MyeloProliferative Neoplasm Treated With Anti-inflammatory Immunotherapy (OPIUM)

June 25, 2024 updated by: University Hospital, Brest
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 Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHU Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

MyeloProliferative Neoplasm patients followed in one of the centres participating to the FIM (French Intergroup- MPN) group

Description

Inclusion Criteria:

  • MyeloProliferative Neoplasm diagnosis
  • receiving or having received an immunotherapy targeting IL-1, IL-6, IL-17, IL-23 or TNF

Exclusion Criteria:

  • Unable to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 25, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC24.0155 - OPIUM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning three years and ending fifteen years following the final study report completion

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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