- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02760238
Myeloproliferative Neoplasms (MPNs) Patient Registry
Clinical and Molecular Epidemiology of Myeloproliferative Neoplasms (MPNs)
Study Overview
Status
Conditions
- Neoplasms
- Primary Myelofibrosis
- Polycythemia Vera
- Essential Thrombocythemia
- Leukemia, Myelomonocytic, Chronic
- Leukemia, Myelomonocytic, Juvenile
- Myelodysplastic-Myeloproliferative Diseases
- Mastocytosis
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
- Chronic Eosinophilic Leukemia-not Otherwise Specified
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Vikas Gupta, MD
- Phone Number: 4521 416-946-4521
- Email: vikas.gupta@uhn.ca
Study Contact Backup
- Name: Jaime O. Claudio, PhD
- Phone Number: 2648 416-946-4501
- Email: jclaudio@uhnresearch.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1Z5
- Recruiting
- Princess Margaret Cancer Centre
-
Contact:
- Vikas Gupta, MD
- Phone Number: 416-946-2885
- Email: vikas.gupta@uhn.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with a diagnosis of MPN
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival
Time Frame: Annually or at the time of transformation of disease, up to 10 years
|
Survival of patients with MPN
|
Annually or at the time of transformation of disease, up to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Type and phase of MPN, previous cancer history, age, sex
|
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
|
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
|
Quality of life - Neoplasm Symptom
Time Frame: Annually or at the time of transformation of disease, up to 10 years
|
MPN-SAF TSS questionnaire
|
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
|
HCT-CI
|
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
|
Physical examination: Splenomegaly and hepatomegaly, ascites, EMS, ECOG
|
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
|
Medical therapies received
|
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
|
Transfusion status
|
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
|
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
|
Identifying MPN driver mutations by using next generation sequencing.
Time Frame: Annually or at the time of transformation of disease, up to 10 years
|
Next generation sequencing gene panel
|
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
|
Details of recipient (CMV status, ABO blood group)
|
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
|
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
|
Portal hypertension
Time Frame: Annually or at the time of transformation of disease, up to 10 years
|
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
|
Pulmonary hypertension
Time Frame: Annually or at the time of transformation of disease, up to 10 years
|
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
|
Thrombosis
Time Frame: Annually or at the time of transformation of disease, up to 10 years
|
Details of thrombosis (type, site) o Treatment of thrombosis (type, duration) |
Annually or at the time of transformation of disease, up to 10 years
|
Family history of MPN will be obtained from the patient record.
Time Frame: Annually or at the time of transformation of disease, up to 10 years
|
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
|
Disease progression
Time Frame: Annually or at the time of transformation of disease, up to 10 years
|
Risk stratification (IPSS, DIPSS and DIPSS)
|
Annually or at the time of transformation of disease, up to 10 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vikas Gupta, MD, University Health Network, Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms by Site
- Disease Attributes
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Blood Platelet Disorders
- Leukocyte Disorders
- Neoplasms, Connective Tissue
- Eosinophilia
- Bone Marrow Neoplasms
- Hematologic Neoplasms
- Chronic Disease
- Mast Cell Activation Disorders
- Neoplasms
- Primary Myelofibrosis
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelomonocytic, Chronic
- Leukemia, Myelomonocytic, Juvenile
- Thrombocytosis
- Thrombocythemia, Essential
- Hypereosinophilic Syndrome
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
- Polycythemia Vera
- Polycythemia
- Mastocytosis
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Other Study ID Numbers
- UHN REB 15-9814 CE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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