An observational study in Primary Myelofibrosis, Polycythemia Vera and Essential Thrombocythemia, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by University Health Network, Toronto · Observational
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.
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).
625 studies on the registry are indexed under Primary Myelofibrosis; 124 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 125 across 73 observational studies indexed under Primary Myelofibrosis.
Browse Primary Myelofibrosis studies →University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients at Princess Margaret Cancer Centre with an MPN diagnosis who consent to inclusion in this registry.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of one of the following myeloproliferative neoplasms (MPNs):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with a myeloproliferative neoplasm (MPN) diagnosis: Atypical chronic myeloid leukemia (aCML), chronic eosinophilic leukemia-not otherwise specified (CEL NOS), chronic myelomonocytic leukemia (CMML), chronic neutrophilic leukemia (CNL), polycythemia vera (PV), essential thrombocythemia (ET), JMML, mastocytosis, MPN unclassifiable, myeloproliferative neoplasm/myelodysplastic syndrome unclassifiable (MPN/MDS unclassifiable), primary myelofibrosis (PMF), post-ET MF, post-PV MF, or (refractory anemia with ringed sideroblasts associated with marked thrombocytosis) RARS-T
Other: Observational
Survival
Survival of patients with MPN
Time frame: Annually or at the time of transformation of disease, up to 10 years
General patient characteristics will be captured from the Hematologic Malignancy tissue bank
Type and phase of MPN, previous cancer history, age, sex
Time frame: Annually or at the time of transformation of disease, up to 10 years
Disease risk score
Risk stratification (IPSS, DIPSS and DIPSS) o Details of transformation to accelerated/phase phase disease
Time frame: Annually or at the time of transformation of disease, up to 10 years
Quality of life - Neoplasm Symptom
MPN-SAF TSS questionnaire
Time frame: Annually or at the time of transformation of disease, up to 10 years
Co-morbidities
HCT-CI
Time frame: Annually or at the time of transformation of disease, up to 10 years
Physical symptoms of MPN
Physical examination: Splenomegaly and hepatomegaly, ascites, EMS, ECOG
Time frame: Annually or at the time of transformation of disease, up to 10 years
MPN treatment type received
Medical therapies received
Time frame: Annually or at the time of transformation of disease, up to 10 years
Transfusion dependence status
Transfusion status
Time frame: Annually or at the time of transformation of disease, up to 10 years
Current Blood Work
CBC, INR, PT, APTT, fibrinogen, creatinine, ALP, ALT, AST, GGT, total bilirubin, LDH, urate, CRP, erythropoietin, hepatitis B and HIV
Time frame: Annually or at the time of transformation of disease, up to 10 years
Identifying MPN driver mutations by using next generation sequencing.
Next generation sequencing gene panel
Time frame: Annually or at the time of transformation of disease, up to 10 years
Bone marrow transplant details (if received)
Details of recipient (CMV status, ABO blood group) * Details of donor (gender, CMV status, ABO blood group) * Disease status at time of transplant (blood work disease status) * Transplant details (stem cell source, HLA matching, conditioning intensity \& regimen, serotherapy, GVHD prophylaxis)
Time frame: Annually or at the time of transformation of disease, up to 10 years
Bone marrow transplant complications (if received)
Toxicities, engraftment and chimerism, GVHD, significant infections in the first 100 days
Time frame: Annually or at the time of transformation of disease, up to 10 years
Portal hypertension
Presence and details of ascites, GIT bleeding, esophageal \& gastric varices, cirrhosis and portal hypertensive gastropathy o Endoscopy results
Time frame: Annually or at the time of transformation of disease, up to 10 years
Pulmonary hypertension
WHO classification, echocardiogram results, CNP, troponin, pulmonary function tests, 6 minute walk test distance, blood gas, treatment, complications
Time frame: Annually or at the time of transformation of disease, up to 10 years
Thrombosis
Details of thrombosis (type, site) o Treatment of thrombosis (type, duration)
Time frame: Annually or at the time of transformation of disease, up to 10 years
Family history of MPN will be obtained from the patient record.
Relative affected (e.g. daughter, uncle, mother), details of MPN (type, phase, treatment received)
Time frame: Annually or at the time of transformation of disease, up to 10 years
Disease progression
Risk stratification (IPSS, DIPSS and DIPSS)
Time frame: Annually or at the time of transformation of disease, up to 10 years
Plan to share: Yes — De-identified participant data may be shared for REB approved research studies. Only the data necessary to achieve the study's aims will be shared and all data will be de-identified prior to sharing.
Time frame: Continuing
Access criteria: De-identified participant data may only be shared for REB approved research studies.
No publications or documents are linked to this record.
The record gives a start of Apr 2015, a primary completion of Oct 2027 and a completion of Oct 2027. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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