Myeloproliferative NeoplasmPRODIGENCT06553638
Evaluation of the Prognostic Impact of Decreased Serum beta2 Microglobulin in the First Year of Follow-up of Myeloproliferative Neoplasia (PRODIGE)
An observational study of Myeloproliferative Neoplasm, run by University Hospital, Brest at 1 site in France.
Trial summary
50 patients with a diagnosis of MPN will have an assessment of b2microglobuline at diagnosis and after 1 year. b2mic value decrease will be compared to treatment response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 12 Aug 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
- Adult, Older adult
Study population: Patients with a new diagnosis of MPN
Who may be able to join
- MPN patient diagnosed at one of the participating centers
- over 18 yo
Who cannot join
- Not able to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Prognostic Impact of Decreased Serum beta2 Microglobulin in the First Year of Follow-up of Myeloproliferative Neoplasia
50 patients with a diagnosis of MPN will have an assessment of b2microglobuline at diagnosis and after 1 year. b2mic value decrease will be compared to treatment response.
- Conditions
- Myeloproliferative Neoplasm
- Medical subject headings
- Myeloproliferative Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
b2mic decrease level between responders and non-responders
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 posted14 Aug 2024
- Study start12 Aug 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 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
- NCT06553638
- Sponsor's protocol ID
- 29BRC24.0132 - PRODIGE
- Acronym
- PRODIGE
- Status last verified
- Apr 2024
- First submitted
- 12 Aug 2024
- Last updated
- 14 Aug 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 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prognostic Impact of Decreased Serum beta2 Microglobulin in the First Year of Follow-up of Myeloproliferative Neoplasia
- ClinicalTrials.gov ID
- NCT06553638
- Acronym / sponsor ID
- PRODIGE / 29BRC24.0132 - PRODIGE
- Conditions
- Myeloproliferative Neoplasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 14 Aug 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.
50 patients with a diagnosis of MPN will have an assessment of b2microglobuline at diagnosis and after 1 year. b2mic value decrease will be compared to treatment response.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with a new diagnosis of MPN
Key inclusion criteria (2 listed)
- MPN patient diagnosed at one of the participating centers
- over 18 yo
Key exclusion criteria (1 listed)
- Not able 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
b2mic decrease level between responders and non-responders
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 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, 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 14 Aug 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?
b2mic decrease level between responders and non-responders (time frame: 1 year). 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 14 Aug 2024.