Neoplasms Clinical Trial
Official title:
Clinical and Molecular Epidemiology of Myeloproliferative Neoplasms (MPNs)
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
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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