NCT04525768

Brief Summary

Myeloproliferative neoplasms (MPNs), including polycythemia vera, essential thrombocythemia, and primary myelofibrosis, may lead to gastroesophageal varices. The quality of life, morbidity, and mortality of MPN patients mainly depend on disease-related symptoms, thromboembolic and hemorrhagic complications. Previous studies have shown that JAK2 V617F has a prominent role in vascular risk and MPN-associated gastroesophageal varices. Portal vein thrombosis and portal cavernoma frequently occur in the MPN population and the management of gastroesophageal varices in these patients are sometimes technically difficult. The aim of this study is to investigate the the characteristics of patients with gastroesophageal varices and portal caver cavernoma with or without JAK2 mutation.

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

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

August 20, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

12 months

First QC Date

August 20, 2020

Last Update Submit

August 23, 2020

Conditions

Gastroesophageal VaricesMyeloproliferative NeoplasmPortal Caver CavernomaPortal Hypertension

Keywords

portal hypertensiongastroesophageal varicesjak2 mutationmyeloproliferative Neoplasmportal caver cavernoma

Outcome Measures

Primary Outcomes (1)

  • History of variceal bleeding

    Have a history of the occurrence of gastroesophageal variceal bleeding

    1 day (the same time as diagnosis)

Secondary Outcomes (2)

  • 1-year death rate

    1 year

  • Complications of portal hypertension

    1 year

Study Arms (2)

JAK2 mutation Group

Patients with portal caver cavernoma and gastroesophageal varices and JAK2 Mutation.

Diagnostic Test: JAK2 mutation test

Portal caver cavernoma Group

Patients with portal caver cavernoma and gastroesophageal varices without JAK2 Mutation.

Diagnostic Test: JAK2 mutation test

Interventions

JAK2 mutation testDIAGNOSTIC_TEST

Patients with portal caver cavernoma will be divided into two groups by the result of JAK2 mutation test

JAK2 mutation GroupPortal caver cavernoma Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who diagnosed with portal cavernoma and gastric and/or esophageal varices and underwent JAK2 mutation test.

You may qualify if:

  • male or female patients aged 18-75
  • diagnosed as portal hypertension and portal cavernoma by contrast-enhanced computed tomography
  • underwent JAK2 mutation test

You may not qualify if:

  • combined known etiologies of chronic liver disease, including hepatitis, primary biliary cirrhosis, schistosomiasis, and non-alcoholic fatty liver disease.
  • other factors judged by the investigator that may affect the safety of the subject or the compliance of the trial. Such as serious illnesses (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (2)

  • Reilly CR, Babushok DV, Martin K, Spivak JL, Streiff M, Bahirwani R, Mondschein J, Stein B, Moliterno A, Hexner EO. Multicenter analysis of the use of transjugular intrahepatic portosystemic shunt for management of MPN-associated portal hypertension. Am J Hematol. 2017 Sep;92(9):909-914. doi: 10.1002/ajh.24798. Epub 2017 Jul 26.

    PMID: 28543980RESULT

  • Yan M, Geyer H, Mesa R, Atallah E, Callum J, Bartoszko J, Yee K, Maganti M, Wong F, Gupta V. Clinical features of patients with Philadelphia-negative myeloproliferative neoplasms complicated by portal hypertension. Clin Lymphoma Myeloma Leuk. 2015 Jan;15(1):e1-5. doi: 10.1016/j.clml.2014.04.004. Epub 2014 Jun 11.

    PMID: 25027569RESULT

MeSH Terms

Conditions

Myeloproliferative DisordersHypertension, Portal

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

August 20, 2020

First Posted

August 25, 2020

Study Start

October 1, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2022

Last Updated

August 25, 2020

Record last verified: 2020-08

Locations

CN(1)