Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT07203768
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.
Study:
NCT07203768
Study Brief:
Protocol Section:
NCT07203768