ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 91 for:    "Hypereosinophilic syndrome"

Myeloproliferative Neoplasms (MPNs) Patient Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02760238
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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.

Condition or disease Intervention/treatment
Primary Myelofibrosis Polycythemia Vera Essential Thrombocythemia Mastocytosis Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Juvenile Chronic Eosinophilic Leukemia-not Otherwise Specified Myelodysplastic-Myeloproliferative Diseases Neoplasms Leukemia, Myelomonocytic, Chronic Other: Observational

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 : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 10 Years
Official Title: Clinical and Molecular Epidemiology of Myeloproliferative Neoplasms (MPNs)
Study Start Date : April 2016
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025


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

Other: Observational



Primary Outcome Measures :
  1. Survival [ Time Frame: Annually or at the time of transformation of disease, up to 10 years ]
    Survival of patients with MPN


Secondary Outcome Measures :
  1. General patient characteristics will be captured from the Hematologic Malignacy 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 [ 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at Princess Margaret Cancer Centre with an MPN diagnosis who consent to inclusion in this registry.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760238


Contacts
Contact: Vikas Gupta, MD 416-946-4521 ext 4521 vikas.gupta@uhn.ca
Contact: Jaime O. Claudio, PhD 416-946-4501 ext 2648 jclaudio@uhnresearch.ca

Locations
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Vikas Gupta, MD    416-946-2885    vikas.gupta@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Vikas Gupta, MD University Health Network, Toronto

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02760238     History of Changes
Other Study ID Numbers: UHN REB 15-9814 CE
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Access Criteria: De-identified participant data may only be shared for REB approved research studies.

Keywords provided by University Health Network, Toronto:
myeloproliferative neoplasm
myelodysplastic syndrome
registry
leukemia
Bone Marrow Diseases
Hematologic Diseases
Neoplasms

Additional relevant MeSH terms:
Hypereosinophilic Syndrome
Leukemia
Neoplasms
Primary Myelofibrosis
Polycythemia
Myeloproliferative Disorders
Polycythemia Vera
Thrombocytosis
Thrombocythemia, Essential
Leukemia, Myeloid
Mastocytosis
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myelomonocytic, Chronic
Myelodysplastic-Myeloproliferative Diseases
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Leukemia, Myelomonocytic, Juvenile
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Skin Diseases
Eosinophilia
Leukocyte Disorders