Impact of Epigenetic Age on Clinic-biological Presentation and Prognosis in Myeloproliferative Neoplasms Epigenetic Age in Myeloproliferative Neoplasms (EpiC)

NCT06022328 | Recruiting

• 1 other identifier: CHUBX 2023/15
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Myeloproliferative Neoplasms (MPN) are hematological malignancies characterized by the excessive production of myeloid cells. MPN can be complicated by thrombosis and evolution into more aggressive diseases (myelofibrosis and acute leukemia). Aging remains the principal factor determining patients' survival in MPN. In recent years, DNA methylation has appeared as a mean to measure aging via the development of epigenetic clocks that have also been associated with the occurrence of thrombosis and cancer. The epiC project aims at determining epigenetic age of MPN patients and search for an association between this parameter and thrombotic/hematological complications.

Conditions

Myeloproliferative Neoplasm

Keywords

Myeloproliferative Neoplasm; Epigenetic age; Thrombosis; Myelofibrosis; Leukemia

Outcome Measures

Primary Outcomes (1)

• Accelerated ageing of patients

  Accelerated ageing will be defined as an increased difference between the epigenetic age (calculated from DNA methylation data with the different molecular clocks described: DNAmAge, DNAmHannum, DNAmPhenoAge, DNAmSkinClock, DNAmGrimAge, intrinsic epigenetic age acceleration, extrinsic epigenetic age acceleration) and the chronological age

  At inclusion, up to 1 year after diagnosis

Secondary Outcomes (10)

• Type of MPN (ET, PV or PMF) at diagnosis

  At inclusion, up to 1 year after diagnosis

• Transformation into secondary myelofibrosis or acute leukemia

  From date of inclusion until documentation of the event, assessed up to 5 years

• Occurrence of thrombosis prior to diagnosis or during follow-up of the disease

  Between 1 year before and 2 years after MPN diagnosis

• Leukocytes

  At inclusion, up to 1 year after diagnosis

• Platelets

  At inclusion, up to 1 year after diagnosis

Study Arms (4)

Patients with ET

45 patients with ET: * 15 without thrombotic event (neither at diagnosis nor during follow-up) * 15 with thrombotic events (thrombosis at diagnosis or within 2 years of diagnosis) * 15 who progressed to myelofibrosis or AML during follow-up

Biological: Assessment of the epigenetic age

Patients with PV

45 patients with PV * 15 without thrombotic event (neither at diagnosis nor during follow-up) * 15 with thrombotic event (thrombosis at diagnosis or within 2 years of diagnosis) * 15 who progressed to myelofibrosis or AML during follow-up

Biological: Assessment of the epigenetic age

Patients with PMF

20 patients with PMF: * 10 without transformation into AML * 10 patients who progressed to AML

Biological: Assessment of the epigenetic age

Patients without MPN

10 patients without MPN

Biological: Assessment of the epigenetic age

Interventions

Assessment of the epigenetic age BIOLOGICAL

Retrospective assessment of the epigenetic age on DNA samples obtained at diagnosis

Patients with ET; Patients with PMF; Patients with PV; Patients without MPN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Myeloproliferative Neoplasia (MPN) : Essential Thrombocythemia (ET), Polycythemia Vera (VP) or Primary Myelofibrosis (PMF)

You may qualify if:

• For the 110 patients with MPN:
• Patients with PV, ET or PMF
• DNA extracted from purified granulocytes at time of diagnosis
• No treatment likely to impact DNA methylation (chemotherapy, immunosuppressants in particular)
• For the 10 subjects without MPN:
• Absence of hematological malignancy
• Search for JAK2V617F mutation in the context of reactive thrombocytosis or secondary polycythemia
• Absence of treatment likely to impact DNA methylation (chemotherapy, immunosuppressants in particular)

You may not qualify if:

• For the 110 patients with MPN:
• Patients without PV, ET or PMF
• Patients without purified granulocytes DNA available at time of diagnosis
• Patients treated by cytoreductive drug, demethylating agent, chemotherapy or immunosuppressive therapy at the time of DNA sampling
• Patients with less than 2 years' follow-up
• For the 10 subjects in NMP :
• Patients with hematological malignancy and/or solid cancer
• Patients treated by cytoreductive drug, demethylating agent, chemotherapy or immunosuppressive therapy at the time of DNA sampling

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux, service Hématologie Biologique

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Myeloproliferative Disorders; Thrombosis; Primary Myelofibrosis; Leukemia

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Olivier MANSIER

CONTACT

olivier.mansier@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: September 1, 2023
• Study Start: December 15, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)