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NCT Number: NCT02760238

Myeloproliferative Neoplasms (MPNs) Patient Registry

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.

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Key information

Conditions

Primary Myelofibrosis Blood Coagulation Disorders Blood Platelet Disorders Bone Marrow Diseases Bone Marrow Neoplasms Chronic Disease Chronic Eosinophilic Leukemia-not Otherwise Specified Disease Attributes Eosinophilia Essential Thrombocythemia Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hypereosinophilic Syndrome Immune System Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Juvenile Leukocyte Disorders Mast Cell Activation Disorders Mastocytosis Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Polycythemia Vera Thrombocythemia, Essential Thrombocytosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1Z5, Canada

Location status: Recruiting

Location contact

Vikas Gupta, MD

CONTACT

[email protected]

416-946-2885

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

Primary outcomes

  1. Survival

    Time frame: Annually or at the time of transformation of disease, up to 10 years

    Survival of patients with MPN

Secondary outcomes

  1. 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

  2. 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

  3. Quality of life - Neoplasm Symptom

    Time frame: Annually or at the time of transformation of disease, up to 10 years

    MPN-SAF TSS questionnaire

  4. Co-morbidities

    Time frame: Annually or at the time of transformation of disease, up to 10 years

    HCT-CI

  5. 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

  6. MPN treatment type received

    Time frame: Annually or at the time of transformation of disease, up to 10 years

    Medical therapies received

  7. Transfusion dependence status

    Time frame: Annually or at the time of transformation of disease, up to 10 years

    Transfusion status

  8. 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

  9. 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

  10. 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)

    • 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)

  11. 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

  12. 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

  13. 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

  14. 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)

  15. 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)

  16. Disease progression

    Time frame: Annually or at the time of transformation of disease, up to 10 years

    Risk stratification (IPSS, DIPSS and DIPSS)

Study contacts

Contact information is provided by the study sponsor or research team.

Jaime O. Claudio, PhD

CONTACT

[email protected]

416-946-4501 ext. 2648

Vikas Gupta, MD

CONTACT

[email protected]

416-946-4521 ext. 4521

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Clinical and Molecular Epidemiology of Myeloproliferative Neoplasms (MPNs)

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
May 3, 2016
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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