Gastroesophageal VaricesNCT04525768
Gastroesophageal Varices in Cavernoma
An observational study of Gastroesophageal Varices and Myeloproliferative Neoplasm, run by Shanghai Zhongshan Hospital at 1 site in China.
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, Myeloproliferative Neoplasm, Portal Caver Cavernoma
- What is being tested?
- JAK2 mutation test
- How many people
- 80 participants
- Where
- 1 siteChina
- 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
- Adult, Older adult
Study population: Patients who diagnosed with portal cavernoma and gastric and/or esophageal varices and underwent JAK2 mutation test.
Who may be able to join
- male or female patients aged 18-75
- diagnosed as portal hypertension and portal cavernoma by contrast-enhanced computed tomography
- underwent JAK2 mutation test
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
180 Fenglin Road
Shanghai, Shanghai Municipality, 200032
Xiaoquan HUANG, M.D., +86-18801733835, huangxiaoquan1010@aliyun.com
About this study
Official title: Characteristic of Patients With Gastroesophageal Varices and Portal Cavernoma
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.
- Conditions
- Gastroesophageal Varices, Myeloproliferative Neoplasm, Portal Caver Cavernoma, Portal Hypertension
- Being tested
- JAK2 mutation test
- Keywords
- portal hypertension, gastroesophageal varices, jak2 mutation, myeloproliferative Neoplasm, portal caver cavernoma
- 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.
JAK2 mutation testDiagnostic test
Patients with portal caver cavernoma will be divided into two groups by the result of JAK2 mutation test
| Study group | Role | What they receive |
|---|---|---|
| JAK2 mutation Group | Patients with portal caver cavernoma and gastroesophageal varices and JAK2 Mutation. Receives: Diagnostic Test: JAK2 mutation test | |
| Portal caver cavernoma Group | Patients with portal caver cavernoma and gastroesophageal varices without JAK2 Mutation. Receives: Diagnostic Test: JAK2 mutation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
History of variceal bleeding
Have a history of the occurrence of gastroesophageal variceal bleeding
Measured: 1 day (the same time as diagnosis)
Secondary outcomes (2)
1-year death rate
1-year death rate
Measured: 1 year
Complications of portal hypertension
The concurrence of complications of portal hypertension (ascites, infections, variceal bleeding, et al)
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 posted25 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 (2)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal VaricesStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 80 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
- NCT04525768
- Sponsor's protocol ID
- ZS-cavernoma-EGV
- Status last verified
- Aug 2020
- First submitted
- 20 Aug 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28543980Yan 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 25027569
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristic of Patients With Gastroesophageal Varices and Portal Cavernoma
- ClinicalTrials.gov ID
- NCT04525768
- Acronym / sponsor ID
- ZS-cavernoma-EGV
- Conditions
- Gastroesophageal Varices, Myeloproliferative Neoplasm, Portal Caver Cavernoma, Portal Hypertension
- Keywords
- portal hypertension, gastroesophageal varices, jak2 mutation, myeloproliferative Neoplasm, portal caver cavernoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 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
- 25 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. 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JAK2 mutation Group | – | Diagnostic Test: JAK2 mutation testPatients with portal caver cavernoma and gastroesophageal varices and JAK2 Mutation. |
| Portal caver cavernoma Group | – | Diagnostic Test: JAK2 mutation testPatients with portal caver cavernoma and gastroesophageal varices without JAK2 Mutation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who diagnosed with portal cavernoma and gastric and/or esophageal varices and underwent JAK2 mutation test.
Key inclusion criteria (3 listed)
- male or female patients aged 18-75
- diagnosed as portal hypertension and portal cavernoma by contrast-enhanced computed tomography
- underwent JAK2 mutation test
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| JAK2 mutation testPatients with portal caver cavernoma will be divided into two groups by the result of JAK2 mutation test | Diagnostic test | JAK2 mutation Group, Portal caver cavernoma Group |
Primary outcome
History of variceal bleeding
Time frame: 1 day (the same time as diagnosis)
Have a history of the occurrence of gastroesophageal variceal bleeding
2 secondary outcomes
1-year death rate
Time frame: 1 year
Complications of portal hypertension
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 25 Aug 2020.
- 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.
- Results publication: 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.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Varices and Myeloproliferative Neoplasm, run by Shanghai Zhongshan Hospital at 1 site in China.
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 2 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 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
History of variceal bleeding (time frame: 1 day (the same time as diagnosis)). 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 NCT04525768, which also lists 2 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 25 Aug 2020.