Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-30 @ 11:44 AM
Study NCT ID:
NCT07203768
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes
Sponsor:
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Organization:
Study Overview
Official Title:
Unmasking Polycythemia Vera in Long-Standing Essential Thrombocythemia: A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ET2PV
Brief Summary:
International multicenter retrospective observational study consisting of two parts: a nested case-control study (part A) and a comparative retrospective cohort study (part B).
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: