Myeloproliferative Neoplasms (MPNs) Patient Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational.
- Who it may be relevant to
- Registry conditions: Primary Myelofibrosis, Polycythemia Vera, Essential Thrombocythemia, Mastocytosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical and Molecular Epidemiology of Myeloproliferative Neoplasms (MPNs)
Overview
The mandate of this MPN registry is to collect clinical information, including molecular results, from consenting patients with a variety of MPNs at different time points during the course of their disease.
Detailed description
The myeloproliferative neoplasms (MPNs) are a group of rare hematological malignancies in which the bone marrow cells that produce the body's blood cells develop and function abnormally.
Despite the gains that have already been made in understanding and treatment of MPNs there is much that can still be learned. This registry will establish a clinical annotation database would help to better understand this group of diseases and to more effectively assign individual patients to the optimal therapy and so, improve their outcomes. This project will provide new insights on the molecular profiling of patients with MPN. It will be used as future resource for observational studies related to MPN.
The registry involves the collection of clinical information from patients with diagnosis of MPN at different time points during the course of their disease. The clinical data is collected following written informed consent from the Hematologic Malignancy tissue bank (UHN REB 01-0573C).
Data collected includes: a range of clinical measures, disease-associated factors, details of treatment and its results, complications during treatment, molecular and cytogenetic data, symptom assessment and survival outcome (up to 10 years).
Data will be collected prospectively and retrospectively, in both cases after obtaining written informed consent as per the study standard operating procedure (SOP).
Interventions
- Other Observational
Primary outcome measures
- Survival [Time frame: Annually or at the time of transformation of disease, up to 10 years]
Secondary outcome measures (12)
- General patient characteristics will be captured from the Hematologic Malignancy tissue bank [Time frame: Annually or at the time of transformation of disease, up to 10 years]
- Disease risk score [Time frame: Annually or at the time of transformation of disease, up to 10 years]
- Quality of life - Neoplasm Symptom [Time frame: Annually or at the time of transformation of disease, up to 10 years]
- Co-morbidities [Time frame: Annually or at the time of transformation of disease, up to 10 years]
- Physical symptoms of MPN [Time frame: Annually or at the time of transformation of disease, up to 10 years]
- MPN treatment type received [Time frame: Annually or at the time of transformation of disease, up to 10 years]
- Transfusion dependence status [Time frame: Annually or at the time of transformation of disease, up to 10 years]
- Current Blood Work [Time frame: Annually or at the time of transformation of disease, up to 10 years]
- Identifying MPN driver mutations by using next generation sequencing. [Time frame: Annually or at the time of transformation of disease, up to 10 years]
- Bone marrow transplant details (if received) [Time frame: Annually or at the time of transformation of disease, up to 10 years]
- Bone marrow transplant complications (if received) [Time frame: Annually or at the time of transformation of disease, up to 10 years]
- Portal hypertension [Time frame: Annually or at the time of transformation of disease, up to 10 years]
Eligibility criteria
Inclusion criteria
Diagnosis of one of the following myeloproliferative neoplasms (MPNs):
- Atypical CML (aCML)
- Chronic eosinophilic leukemia-not otherwise specified (CEL, NOS),
- Chronic myelomonocytic leukemia (CMML)
- Chronic neutrophilic leukemia (CNL),
- Essential thrombocythemia (ET),
- Juvenile myelomonocytic leukemia (JMML),
- Mastocytosis, MPN unclassifiable
- MPN/MDS unclassifiable,
- Primary myelofibrosis (PMF),
- Post-essential thrombocythemia myelofibrosis (post-ET MF),
- Post-polycythemia vera MF (post-PV MF)
- Refractory anemia with ringed sideroblasts associated with marked thrombocytosis (RARS-T)
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Princess Margaret Cancer Centre — Toronto
Identifiers
NCT: NCT02760238 · UHN REB 15-9814 CE