Status:
COMPLETED
PREVALENCE STUDY OF PNH CLONES IN PATIENTS WITH NEOPLASIES
Lead Sponsor:
AUSL Romagna Rimini
Conditions:
Myeloproliferative Neoplasm
Eligibility:
All Genders
18-100 years
Brief Summary
Multicenter prevalence study of the PNH clone (paroxysmal hemoglobinuria nocturnal) in SMP Ph-. This multicenter, prospective study aims to evaluate the presence of an PNH clone in patients with a con...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Diagnosis of one of the following Ph-negative myeloproliferative neoplasms:
- polycythemia vera, essential thrombocythemia, idiopathic myelofibrosis, according to i WHO 2016 criteria
- Women or men, age ≥ 18 years.
- Willingness and ability to give written informed consent and adhere to study procedures.
- 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)
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06159816
Start Date
November 1 2017
End Date
January 1 2022
Last Update
December 7 2023
Active Locations (1)
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1
Ausl Della Romagna
Ravenna, Italy, 48121