Gastroesophageal VaricesNCT04527666
Anticoagulation in Gastroesophageal Varices and JAK2 Mutation
An observational study of Gastroesophageal Varices and JAK2 Mutation, run by Shanghai Zhongshan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Varices, JAK2 Mutation, Myeloproliferative Neoplasm
- What is being tested?
- Anticoagulation Agents
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with gastric and/or esophageal varices and JAK2 mutation.
Who may be able to join
- Male or female patients aged 18-75
- diagnosed as portal hypertension by contrast-enhanced computed tomography
- diagnosed as JAK2 positive
Who cannot join
- not had portal contrast-enhanced computed tomography
- not had JAK2 mutation test
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Anticoagulation Treatment of Patients With Gastroesophageal Varices and JAK2 V617 Mutation
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. The aim of this study is to evaluate the efficacy of anticoagulation in patients with JAK2 mutation and gastroesophageal varices.
- Being tested
- Anticoagulation Agents
- Keywords
- portal hypertension, gastroesophageal varices, jak2 mutation, myeloproliferative neoplasm
- Medical subject headings
- Myeloproliferative Disorders, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulation AgentsDrug
Patients receive anticoagulation agents including low molecular weight heparin, warfarin, rivaroxaban, et al.
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulation group | Patients with JAK2 mutation and gastroesophageal varices receive anticoagulation agents. Receives: Drug: Anticoagulation Agents | |
| Control group | Patients with JAK2 mutation and gastroesophageal varices who didn't receive anticoagulation agents. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of portal vein thrombosis
The changes of portal vein thrombosis including progression, disappear or unchanged.
Measured: 1 year
Secondary outcomes (2)
The occurrence of variceal bleeding
The occurrence of variceal bleeding including haematemesis and melena
Measured: 1 year
Overall survival
Overall survival rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal VaricesStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XiaoquanHUANG, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527666
- Sponsor's protocol ID
- ZS-ANTICO-JAK2
- Status last verified
- Aug 2020
- First submitted
- 23 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Greenfield G, McMullin MF. Splanchnic venous thrombosis in JAK2 V617F mutation positive myeloproliferative neoplasms - long term follow-up of a regional case series. Thromb J. 2018 Dec 19;16:33. doi: 10.1186/s12959-018-0187-z. eCollection 2018.
PubMed 30574023Yan 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.
PubMed 25027569Magaz M, Alvarez-Larran A, Colomer D, Lopez-Guerra M, Garcia-Criado MA, Mezzano G, Belmonte E, Olivas P, Soy G, Cervantes F, Darnell A, Ferrusquia-Acosta J, Baiges A, Turon F, Hernandez-Gea V, Garcia-Pagan JC. Next-generation sequencing in the diagnosis of non-cirrhotic splanchnic vein thrombosis. J Hepatol. 2021 Jan;74(1):89-95. doi: 10.1016/j.jhep.2020.06.045. Epub 2020 Jul 15.
PubMed 32679300Reilly 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.
PubMed 28543980
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulation Treatment of Patients With Gastroesophageal Varices and JAK2 V617 Mutation
- ClinicalTrials.gov ID
- NCT04527666
- Acronym / sponsor ID
- ZS-ANTICO-JAK2
- Keywords
- portal hypertension, gastroesophageal varices, jak2 mutation, myeloproliferative neoplasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The aim of this study is to evaluate the efficacy of anticoagulation in patients with JAK2 mutation and gastroesophageal varices.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anticoagulation group | – | Drug: Anticoagulation AgentsPatients with JAK2 mutation and gastroesophageal varices receive anticoagulation agents. |
| Control group | – | –Patients with JAK2 mutation and gastroesophageal varices who didn't receive anticoagulation agents. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gastric and/or esophageal varices and JAK2 mutation.
Key inclusion criteria (3 listed)
- Male or female patients aged 18-75
- diagnosed as portal hypertension by contrast-enhanced computed tomography
- diagnosed as JAK2 positive
Key exclusion criteria (3 listed)
- not had portal contrast-enhanced computed tomography
- not had JAK2 mutation test
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticoagulation AgentsPatients receive anticoagulation agents including low molecular weight heparin, warfarin, rivaroxaban, et al. | Drug | Anticoagulation group |
Primary outcome
Changes of portal vein thrombosis
Time frame: 1 year
The changes of portal vein thrombosis including progression, disappear or unchanged.
2 secondary outcomes
The occurrence of variceal bleeding
Time frame: 1 year
Overall survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Background: PubMed 30574023Greenfield G, McMullin MF. Splanchnic venous thrombosis in JAK2 V617F mutation positive myeloproliferative neoplasms - long term follow-up of a regional case series. Thromb J. 2018 Dec 19;16:33. doi: 10.1186/s12959-018-0187-z. eCollection 2018.
- Background: PubMed 25027569Yan 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.
- Background: PubMed 32679300Magaz M, Alvarez-Larran A, Colomer D, Lopez-Guerra M, Garcia-Criado MA, Mezzano G, Belmonte E, Olivas P, Soy G, Cervantes F, Darnell A, Ferrusquia-Acosta J, Baiges A, Turon F, Hernandez-Gea V, Garcia-Pagan JC. Next-generation sequencing in the diagnosis of non-cirrhotic splanchnic vein thrombosis. J Hepatol. 2021 Jan;74(1):89-95. doi: 10.1016/j.jhep.2020.06.045. Epub 2020 Jul 15.
- Results publication: PubMed 28543980Reilly 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Varices and JAK2 Mutation, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoquan HUANG, Ph.D (18801733835, huang.xiaoquan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of portal vein thrombosis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04527666, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.