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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02760238
Other study ID # UHN REB 15-9814 CE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 2016
Est. completion date October 2025

Study information

Verified date July 2023
Source University Health Network, Toronto
Contact Vikas Gupta, MD
Phone 416-946-4521
Email vikas.gupta@uhn.ca
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date October 2025
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observational


Locations

Country Name City State
Canada Princess Margaret Cancer Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival Survival of patients with MPN Annually or at the time of transformation of disease, up to 10 years
Secondary General patient characteristics will be captured from the Hematologic Malignancy tissue bank Type and phase of MPN, previous cancer history, age, sex Annually or at the time of transformation of disease, up to 10 years
Secondary Disease risk score Risk stratification (IPSS, DIPSS and DIPSS)
o Details of transformation to accelerated/phase phase disease
Annually or at the time of transformation of disease, up to 10 years
Secondary Quality of life - Neoplasm Symptom MPN-SAF TSS questionnaire Annually or at the time of transformation of disease, up to 10 years
Secondary Co-morbidities HCT-CI Annually or at the time of transformation of disease, up to 10 years
Secondary Physical symptoms of MPN Physical examination: Splenomegaly and hepatomegaly, ascites, EMS, ECOG Annually or at the time of transformation of disease, up to 10 years
Secondary MPN treatment type received Medical therapies received Annually or at the time of transformation of disease, up to 10 years
Secondary Transfusion dependence status Transfusion status Annually or at the time of transformation of disease, up to 10 years
Secondary Current Blood Work CBC, INR, PT, APTT, fibrinogen, creatinine, ALP, ALT, AST, GGT, total bilirubin, LDH, urate, CRP, erythropoietin, hepatitis B and HIV Annually or at the time of transformation of disease, up to 10 years
Secondary Identifying MPN driver mutations by using next generation sequencing. Next generation sequencing gene panel Annually or at the time of transformation of disease, up to 10 years
Secondary 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)
Annually or at the time of transformation of disease, up to 10 years
Secondary Bone marrow transplant complications (if received) Toxicities, engraftment and chimerism, GVHD, significant infections in the first 100 days Annually or at the time of transformation of disease, up to 10 years
Secondary Portal hypertension Presence and details of ascites, GIT bleeding, esophageal & gastric varices, cirrhosis and portal hypertensive gastropathy
o Endoscopy results
Annually or at the time of transformation of disease, up to 10 years
Secondary Pulmonary hypertension WHO classification, echocardiogram results, CNP, troponin, pulmonary function tests, 6 minute walk test distance, blood gas, treatment, complications Annually or at the time of transformation of disease, up to 10 years
Secondary Thrombosis Details of thrombosis (type, site)
o Treatment of thrombosis (type, duration)
Annually or at the time of transformation of disease, up to 10 years
Secondary 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) Annually or at the time of transformation of disease, up to 10 years
Secondary Disease progression Risk stratification (IPSS, DIPSS and DIPSS) Annually or at the time of transformation of disease, up to 10 years
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