NCT03599700

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1.4 years until next milestone

Study Start

First participant enrolled

December 20, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

June 28, 2018

Last Update Submit

February 18, 2021

Conditions

Thrombosis

Keywords

thrombosismyeloproliferative neoplasms

Outcome Measures

Primary Outcomes (1)

  • Incidence of thromboembolic events in Philadelphia negative myeloproliferative neoplasms

    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

    3 years

Secondary Outcomes (1)

  • survival of patients with Philadelphia negative myeloproliferative neoplasms

    3 years

Study Arms (1)

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

Interventions

myeloproliferative neoplasmsDIAGNOSTIC_TEST

BLOOD SAMPLING

myeloproliferative neoplasms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

prospective cohort study

You may qualify if:

  • age \> 18 years
  • All patients diagnosed as BCR-ABL negative myeloproliferative neoplasm e.g:
  • Polycythemia vera Essential thrombocythemia Primary myelofibrosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hematology Unit

Asyut, 22413749, Egypt

RECRUITING

Related Publications (14)

  • Barbui T, Finazzi G, Falanga A. Myeloproliferative neoplasms and thrombosis. Blood. 2013 Sep 26;122(13):2176-84. doi: 10.1182/blood-2013-03-460154. Epub 2013 Jul 3.

    PMID: 23823316BACKGROUND

  • Marin Oyarzun CP, Carestia A, Lev PR, Glembotsky AC, Castro Rios MA, Moiraghi B, Molinas FC, Marta RF, Schattner M, Heller PG. Neutrophil extracellular trap formation and circulating nucleosomes in patients with chronic myeloproliferative neoplasms. Sci Rep. 2016 Dec 13;6:38738. doi: 10.1038/srep38738.

    PMID: 27958278BACKGROUND

  • Ball S, Thein KZ, Maiti A, Nugent K. Thrombosis in Philadelphia negative classical myeloproliferative neoplasms: a narrative review on epidemiology, risk assessment, and pathophysiologic mechanisms. J Thromb Thrombolysis. 2018 May;45(4):516-528. doi: 10.1007/s11239-018-1623-4.

    PMID: 29404876BACKGROUND

  • Zhang W, Qi J, Zhao S, Shen W, Dai L, Han W, Huang M, Wang Z, Ruan C, Wu D, Han Y. Clinical significance of circulating microparticles in Ph- myeloproliferative neoplasms. Oncol Lett. 2017 Aug;14(2):2531-2536. doi: 10.3892/ol.2017.6459. Epub 2017 Jun 22.

    PMID: 28789461BACKGROUND

  • How J, Zhou A, Oh ST. Splanchnic vein thrombosis in myeloproliferative neoplasms: pathophysiology and molecular mechanisms of disease. Ther Adv Hematol. 2017 Mar;8(3):107-118. doi: 10.1177/2040620716680333. Epub 2016 Dec 8.

    PMID: 28246554BACKGROUND

  • Tefferi A. Polycythemia vera and essential thrombocythemia: 2013 update on diagnosis, risk-stratification, and management. Am J Hematol. 2013 Jun;88(6):507-16. doi: 10.1002/ajh.23417.

    PMID: 23695894BACKGROUND

  • Kissova J, Bulikova A, Ovesna P, Bourkova L, Penka M. Increased mean platelet volume and immature platelet fraction as potential predictors of thrombotic complications in BCR/ABL-negative myeloproliferative neoplasms. Int J Hematol. 2014 Nov;100(5):429-36. doi: 10.1007/s12185-014-1673-0. Epub 2014 Sep 17.

    PMID: 25227185BACKGROUND

  • Lussana F, Carobbio A, Salmoiraghi S, Guglielmelli P, Vannucchi AM, Bottazzi B, Leone R, Mantovani A, Barbui T, Rambaldi A. Driver mutations (JAK2V617F, MPLW515L/K or CALR), pentraxin-3 and C-reactive protein in essential thrombocythemia and polycythemia vera. J Hematol Oncol. 2017 Feb 22;10(1):54. doi: 10.1186/s13045-017-0425-z.

    PMID: 28228104BACKGROUND

  • Gortzen J, Hunka LM, Vonnahme M, Praktiknjo M, Kaifie A, Fimmers R, Jansen C, Heine A, Lehmann J, Goethert JR, Gattermann N, Goekkurt E, Platzbecker U, Brossart P, Strassburg CP, Brummendorf TH, Koschmieder S, Wolf D, Trebicka J. gamma-Glutamyl Transferase Is an Independent Biomarker of Splanchnic Thrombosis in Patients With Myeloproliferative Neoplasm. Medicine (Baltimore). 2016 May;95(20):e3355. doi: 10.1097/MD.0000000000003355.

    PMID: 27196445BACKGROUND

  • Lamy M, Palazzo P, Agius P, Chomel JC, Ciron J, Berthomet A, Cantagrel P, Prigent J, Ingrand P, Puyade M, Neau JP. Should We Screen for Janus Kinase 2 V617F Mutation in Cerebral Venous Thrombosis? Cerebrovasc Dis. 2017;44(3-4):97-104. doi: 10.1159/000471891. Epub 2017 Jun 14.

    PMID: 28609766BACKGROUND

  • Mahe K, Delluc A, Chauveau A, Castellant P, Mottier D, Dalbies F, Berthou C, Guillerm G, Lippert E, Ianotto JC. Incidence and impact of atrial arrhythmias on thrombotic events in MPNs. Ann Hematol. 2018 Jan;97(1):101-107. doi: 10.1007/s00277-017-3164-x. Epub 2017 Nov 21.

    PMID: 29164292BACKGROUND

  • Haybar H, Khodadi E, Shahjahani M, Saki N. Cardiovascular Events: A Challenge in JAK2-positive Myeloproliferative Neoplasms. Cardiovasc Hematol Disord Drug Targets. 2017;17(3):161-166. doi: 10.2174/1871529X17666171030122345.

    PMID: 29086702BACKGROUND

  • Le Calloch R, Lacut K, Le Gall-Ianotto C, Nowak E, Abiven M, Tempescul A, Dalbies F, Eveillard JR, Ugo V, Giraudier S, Guillerm G, Lippert E, Berthou C, Ianotto JC. Non-adherence to treatment with cytoreductive and/or antithrombotic drugs is frequent and associated with an increased risk of complications in patients with polycythemia vera or essential thrombocythemia (OUEST study). Haematologica. 2018 Apr;103(4):607-613. doi: 10.3324/haematol.2017.180448. Epub 2017 Dec 15.

    PMID: 29246923BACKGROUND

  • Martin K. Risk Factors for and Management of MPN-Associated Bleeding and Thrombosis. Curr Hematol Malig Rep. 2017 Oct;12(5):389-396. doi: 10.1007/s11899-017-0400-3.

    PMID: 28948496BACKGROUND

MeSH Terms

Conditions

ThrombosisMyeloproliferative Disorders

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • howida nafady

    extracted from this organization's records

    STUDY DIRECTOR

Central Study Contacts

maha mohammed

CONTACT

01097278659maha.azez@yahoo.com

safenazh hussein

CONTACT

01007711092drsafenazh@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 26, 2018

Study Start

December 20, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

EG(1)