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NCT Number: NCT07203768

A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes

International multicenter retrospective observational study consisting of two parts: a nested case-control study (part A) and a comparative retrospective cohort study (part B).

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Halle, Halle, Germany

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About this study

The study will include ET patients (diagnosed according to "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria) who are JAK2V617F positive and have progressed to PV (diagnosed according to "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria) by 31/12/2020. The date of PV diagnosis will be defined as the index date and this group of patients will be defined as ET-to-PV cases.

Part A - Nested case-control study Controls for ET-to-PV cases will be patients diagnosed with ET, according to the "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria, JAK2V617F positive who did not progress to PV after a comparable period of time. This control group will be selected using a 1:1 matched case-control design.

For each patient who progressed to PV (case), a control will be selected with the following characteristics:

  • year of ET diagnosis (+/-2 years as compared to the date of the case);
  • age at ET diagnosis (+/-3 years as compared to the age of the case);
  • duration of ET disease (+/-2 years as compared to the period between the diagnosis of ET and the index date of the respective case).

Part B - Comparative retrospective cohort study

Patients diagnosed with de novo PV (no progression from previous ET) according to the "International consensus classification of myeloid neoplasms and acute leukemias - 2022" data criteria, will be recruited using a 1:1 matching procedure according to the following characteristics:

  • year of PV diagnosis (+/-2 years as compared to the date of the case);
  • age at PV diagnosis (+/-3 years as compared to the age of the case);
  • duration of PV disease (+/-2 years as compared to the period between PV diagnosis and the last follow-up of the respective case).

Furthermore, to have at least 5 years of follow-up, de novo PV patients must be diagnosed no later than 2020.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ET patients (diagnosed according to "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria) who are JAK2V617F positive and have progressed to PV (diagnosed according to "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria) by 31/12/2020. The date of PV diagnosis will be defined as the index date and this group of patients will be defined as ET-to-PV cases.

Exclusion criteria

  • None.

Treatment and study plan

Primary outcomes

  1. Nested case-control study

    Time frame: Up to the baseline

    To identify proliferative risk factors for progression from ET to PV in JAK2V617F positive patients.

  2. Comparative retrospective cohort study

    Time frame: Up to the baseline

    To evaluate the different disease prognosis in ET patients who have progressed to PV compared to de novo PV patients.

Secondary outcomes

  1. Nested case-control study

    Time frame: At the time of progression

    To describe characteristics of ET patients who progressed to PV, including the timing of progression.

  2. Comparative retrospective cohort study

    Time frame: At the time of progression

    To compare the incidence of different outcomes (vascular events, progression to myelofibrosis, progression to acute myeloid leukaemia, tumours, death) in ET patients who progressed to PV and in de novo PV patients.

Study contacts

Contact information is provided by the study sponsor or research team.

FRANCESCA FENILI

CONTACT

[email protected]

TIZIANO BARBUI, MD

CONTACT

[email protected]

+39 0352675134

Sponsors and collaborators

Lead sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Other

Registry information

Official study title

Unmasking Polycythemia Vera in Long-Standing Essential Thrombocythemia: A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes

Acronym: ET2PV

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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