Primary ThrombocytosisNCT05921838
The Role of Circ0014614 in the Formation and Development of ET
An observational study of Primary Thrombocytosis, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Research on the Role of Circ0014614 in the Formation and Development of ET Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Primary Thrombocytosis
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2023
- 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 64 years
- All sexes
- Adult
Study population: ET patients treated with interferon
Who may be able to join
- According to the classification and diagnostic criteria of hematological myeloid tumors by WHO 2016, patients diagnosed as ET are standardized
- Voluntary signing of informed consent form
- Age ≥ 18 years old, regardless of gender
- No pregnancy plan during treatment
Who cannot join
- 1.The researcher judged that it was not suitable to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Dan Xu, +86-20-61641615, 522111156@qq.com
Xiaofan Chen, +86-20-61641615, 522111156@qq.com
About this study
Research on the Role of Circ0014614 in the Formation and Development of ET
Read the detailed description
In recent years, tumor niche involved in the development of myeloproliferative disease（MPN）, which is remodelled by stem progenitor cells driving gene mutation, has attracted attention, but the reason and mechanism of remodelling microenvironment by mutated hematopoietic stem cells（ HSCs） are poorly understood. Our previous studies have shown that there is an obstacle in the transport of extracellular vesicles circ0014614 from MEPs in ET patients, which is enriched in the cytoplasm of megakaryocyte-erythroid progenitor（MEPs）, causing abnormal proliferation and reduced apoptosis of MEPs. The amplified MEPs affect the ossification of Mesenchymal stem cells（MCSs）. Based on this, we propose a hypothesis that circ0014614 may cause abnormal amplification of MEPs, reshape niche, induce ossification of MCSs, and abnormal amplification of osteoblasts（OBCs） through a certain pathway, promoting the formation and development of ET. This study will expand the collection of bone marrow samples from Essential thrombocytosis（ET） patients, detect the differences in circ0014614 levels in peripheral blood and bone marrow before and after treatment, and predict its downstream microRNA and mRNA through bioinformatics analysis to speculate its role in the occurrence and development of the disease. In recent years, tumor niche involved in the development of MPN, which is remodelled by stem progenitor cells driving gene mutation, has attracted attention, but the reason and mechanism of remodelling microenvironment by mutated HSCs are poorly understood. Our previous research has shown that there is an obstacle in the transport of extracellular vesicles circ0014614 from MEPs in ET patients, which is enriched in the cytoplasm of MEPs, causing abnormal proliferation and reduced apoptosis of MEPs. The amplified MEPs affect the ossification of MCSs. Based on this, we propose a hypothesis that circ0014614 may cause abnormal amplification of MEPs, reshape niche, induce ossification of MCSs, and abnormal amplification of OBCs through a certain pathway, promoting the formation and development of ET. This study will expand the collection of bone marrow samples from ET patients, detect the differences in circ0014614 levels in peripheral blood and bone marrow before and after treatment, and predict its downstream microRNA and mRNA through bioinformatics analysis to speculate its role in the occurrence and development of the disease.
- Conditions
- Primary Thrombocytosis
- Medical subject headings
- Thrombocythemia, Essential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| ET patients | patients suffer from primary thrombocytosis | |
| healthy doner | Healthy individuals without blood system diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circ0014614 copies in ET patients treated with interferon for 8 months
Circ0014614 copies in ET patients treated with interferon for 8 months
Measured: 8months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary ThrombocytosisStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Xu, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921838
- Sponsor's protocol ID
- NFEC-2023-173
- Status last verified
- Jun 2023
- First submitted
- 31 May 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Circ0014614 in the Formation and Development of ET
- ClinicalTrials.gov ID
- NCT05921838
- Acronym / sponsor ID
- NFEC-2023-173
- Conditions
- Primary Thrombocytosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Jun 2023 (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.
Research on the Role of Circ0014614 in the Formation and Development of ET
Detailed description
In recent years, tumor niche involved in the development of myeloproliferative disease（MPN）, which is remodelled by stem progenitor cells driving gene mutation, has attracted attention, but the reason and mechanism of remodelling microenvironment by mutated hematopoietic stem cells（ HSCs） are poorly understood. Our previous studies have shown that there is an obstacle in the transport of extracellular vesicles circ0014614 from MEPs in ET patients, which is enriched in the cytoplasm of megakaryocyte-erythroid progenitor（MEPs）, causing abnormal proliferation and reduced apoptosis of MEPs. The amplified MEPs affect the ossification of Mesenchymal stem cells（MCSs）. Based on this, we propose a hypothesis that circ0014614 may cause abnormal amplification of MEPs, reshape niche, induce ossification of MCSs, and abnormal amplification of osteoblasts（OBCs） through a certain pathway, promoting the formation and development of ET. This study will expand the collection of bone marrow samples from Essential thrombocytosis（ET） patients, detect the differences in circ0014614 levels in peripheral blood and bone marrow before and after treatment, and predict its downstream microRNA and mRNA through bioinformatics analysis to speculate its role in the occurrence and development of the disease. In recent years, tumor niche involved in the development of MPN, which is remodelled by stem progenitor cells driving gene mutation, has attracted attention, but the reason and mechanism of remodelling microenvironment by mutated HSCs are poorly understood. Our previous research has shown that there is an obstacle in the transport of extracellular vesicles circ0014614 from MEPs in ET patients, which is enriched in the cytoplasm of MEPs, causing abnormal proliferation and reduced apoptosis of MEPs. The amplified MEPs affect the ossification of MCSs. Based on this, we propose a hypothesis that circ0014614 may cause abnormal amplification of MEPs, reshape niche, induce ossification of MCSs, and abnormal amplification of OBCs through a certain pathway, promoting the formation and development of ET. This study will expand the collection of bone marrow samples from ET patients, detect the differences in circ0014614 levels in peripheral blood and bone marrow before and after treatment, and predict its downstream microRNA and mRNA through bioinformatics analysis to speculate its role in the occurrence and development of the disease.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ET patients | – | –patients suffer from primary thrombocytosis |
| healthy doner | – | –Healthy individuals without blood system diseases |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Age groups
- Adult
- Study population
- ET patients treated with interferon
Key inclusion criteria (4 listed)
- According to the classification and diagnostic criteria of hematological myeloid tumors by WHO 2016, patients diagnosed as ET are standardized
- Voluntary signing of informed consent form
- Age ≥ 18 years old, regardless of gender
- No pregnancy plan during treatment
Key exclusion criteria (1 listed)
- 1.The researcher judged that it was not suitable to participate in this study
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 |
|---|---|---|
| Other | ET patients, healthy doner |
Primary outcome
Circ0014614 copies in ET patients treated with interferon for 8 months
Time frame: 8months
Circ0014614 copies in ET patients treated with interferon for 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Dan Xu principal investigator
Nanfang Hospital, Southern Medical University
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 Primary Thrombocytosis, run by Nanfang Hospital, Southern Medical University 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 4 inclusion and 1 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 Jun 2023. 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?
Contact Dan Xu (+86-20-61641615, 522111156@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circ0014614 copies in ET patients treated with interferon for 8 months (time frame: 8months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2023.