Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Risk Factors and Predictors of Thrombosis in Myeloprolferative Neoplasms

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: NCT03599700
Recruitment Status : Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Maha Mohammed Abdel-Aziz, Assiut University

Brief Summary:
To assess the clinical risk factors and predictable biomarkers of thrombotic complications in cases of philadelphia negative myeloproliferative disorders.

Condition or disease Intervention/treatment
Thrombosis Diagnostic Test: myeloproliferative neoplasms

Show Show detailed description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 118 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Risk Factors and Predictors of Thrombosis in Patients With Philadelphia Negative Myeloprolferative Neoplasms
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Group/Cohort Intervention/treatment
myeloproliferative neoplasms
  • history taking
  • physical examination
  • laboratory investigations: Complete blood counts Bone marrow examination JAK2 V617F mutation. High-sensitivity C-reactive protein ESR Uric acid level LDH GGT BCR- ABL fusion gene IL-8 , TNF-Alpha Serum ferritin Serum albumin, transferrin, alpha feto protein Complement system: C3, C4.
Diagnostic Test: myeloproliferative neoplasms
BLOOD SAMPLING




Primary Outcome Measures :
  1. Incidence of thromboembolic events in Philadelphia negative myeloproliferative neoplasms [ Time Frame: 3 years ]
    Incidence of thromboembolic events e.g. portal vein thrombosis, deep venous thrombosis or pulmonary embolism at patients newly diagnosed as philadelphia negative myeloproliferative neoplasms during the period of the study


Secondary Outcome Measures :
  1. survival of patients with Philadelphia negative myeloproliferative neoplasms [ Time Frame: 3 years ]
    life expectancy and causes of death( e.g. thrombosis, bleeding, infections, leukemic transformation)



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
prospective cohort study
Criteria

Inclusion Criteria:

age > 18 years

All patients diagnosed as BCR-ABL negative myeloproliferative neoplasm e.g:

Polycythemia vera Essential thrombocythemia Primary myelofibrosis

Exclusion Criteria:

  • BCR- ABL positive MPN e.g CML
  • Secondary erythrocytosis.
  • Secondary thrombocytosis.
  • Secondary bone marrow fibrosis.

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): NCT03599700


Contacts
Layout table for location contacts
Contact: maha mohammed 01097278659 maha.azez@yahoo.com
Contact: safenazh hussein 01007711092 drsafenazh@gmail.com

Locations
Layout table for location information
Egypt
Clinical Hematology Unit
Assiut, Egypt, 22413749
Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Study Director: howida nafady extracted from this organization's records

Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Maha Mohammed Abdel-Aziz, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03599700    
Other Study ID Numbers: MPN
HABIBA ( Other Identifier: clinical hematology unit )
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maha Mohammed Abdel-Aziz, Assiut University:
thrombosis
myeloproliferative neoplasms
Additional relevant MeSH terms:
Layout table for MeSH terms
Thrombosis
Neoplasms
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases