Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
NCT ID:
NCT06159816
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of one of the following Ph-negative myeloproliferative neoplasms:
polycythemia vera, essential thrombocythemia, idiopathic myelofibrosis, according to i WHO 2016 criteria
2. Women or men, age ≥ 18 years.
3. Willingness and ability to give written informed consent and adhere to study procedures.
4. Availability of the result of the following molecular tests:
* JAK2-V617F mutation,
* JAK2 exon 12 in PV (if JAK2 negative) Cal-R, and MPL in MFI and TE (if JAK2 negative)
5. Obvious signs of hemolysis (defined as LDH≥1.5 x ULN, reduced haptoglobin, reticulocytosis) when not related to the underlying disease or significantly changed compared to baseline values OR Detection of a thrombotic event (subsequent to diagnosis) OR Appearance or worsening of anemia OR Symptom change (appearance or worsening of signs or symptoms) in a stable disease context.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06159816
Study Brief:
Protocol Section:
NCT06159816