ThrombosisNCT01878916
Plasma Vitamin and Homocysteine Levels and Thrombosis in Patients With Ph-negative MPNs
An observational study of Thrombosis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Hyperhomocysteinemia is a risk for thrombosis. Thrombosis is more frequent in myeloproliferative neoplasms (MPNs) than the normal population. In this study, we investigated the thrombosis incidence, the effects of plasma homocysteine levels on thrombosis, and the correlations between folate, cobalamin, pyridoxine and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- How many people
- Not given
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2003to Jun 2004
- How long will I take part?
- 12 Months
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Between January and June 2003, thirty-one new or formerly diagnosed MPN patients who consecutively visitted our clinic, as well as 40 age and sex matched healthy controls were enrolled in this study.
Who may be able to join
- Adult MPN patients and healthy controls who gave a written consent were included in the study.
Who cannot join
- Exclusion criteria included not giving a written consent and using medications without an indication which may have an effect on plasma homocysteine and vitamin levels.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa Medical Faculty
Istanbul
About this study
Official title: Plasma Cobalamin, Folate, Pyridoxine and Homocysteine Levels and Thrombosis in Patients With Philadelphia-chromosome-negative Myeloproliferative Neoplasms
Hyperhomocysteinemia is a risk for thrombosis. Thrombosis is more frequent in myeloproliferative neoplasms (MPNs) than the normal population. In this study, we investigated the thrombosis incidence, the effects of plasma homocysteine levels on thrombosis, and the correlations between folate, cobalamin, pyridoxine and homocysteine levels in MPNs, and to compare these results with the healthy controls.
Read the detailed description
Thirty-one new or formerly diagnosed MPN patients who consecutively visitted our outpatient clinic, as well as 40 age and sex matched healthy controls were enrolled in this study.
- Conditions
- Thrombosis
- Keywords
- the incidence of thrombosis,, the effect of Hcy on thrombosis formation,, the relation between Hcy and plasma vitamin levels,, to compare these results with the control group
- Medical subject headings
- Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombosis
Measured: at least 1 year
Secondary outcomes (1)
High Hcy level
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 posted17 Jun 2013 (estimated)
- Study startJan 2003
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Cohort
- Time perspective
- Prospective
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. A. Emre Eşkazan, Istanbul University
- Investigators
- Ahmet Emre Eskazan, MD, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878916
- Sponsor's protocol ID
- HcyMPN
- Status last verified
- Jun 2013
- First submitted
- 29 May 2013
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Cobalamin, Folate, Pyridoxine and Homocysteine Levels and Thrombosis in Patients With Philadelphia-chromosome-negative Myeloproliferative Neoplasms
- ClinicalTrials.gov ID
- NCT01878916
- Acronym / sponsor ID
- HcyMPN
- Conditions
- Thrombosis
- Keywords
- the incidence of thrombosis,, the effect of Hcy on thrombosis formation,, the relation between Hcy and plasma vitamin levels,, to compare these results with the control group
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 17 Jun 2013 (estimated)
- 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.
Hyperhomocysteinemia is a risk for thrombosis. Thrombosis is more frequent in myeloproliferative neoplasms (MPNs) than the normal population. In this study, we investigated the thrombosis incidence, the effects of plasma homocysteine levels on thrombosis, and the correlations between folate, cobalamin, pyridoxine and homocysteine levels in MPNs, and to compare these results with the healthy controls.
Detailed description
Thirty-one new or formerly diagnosed MPN patients who consecutively visitted our outpatient clinic, as well as 40 age and sex matched healthy controls were enrolled in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Between January and June 2003, thirty-one new or formerly diagnosed MPN patients who consecutively visitted our clinic, as well as 40 age and sex matched healthy controls were enrolled in this study.
Key inclusion criteria (1 listed)
- Adult MPN patients and healthy controls who gave a written consent were included in the study.
Key exclusion criteria (1 listed)
- Exclusion criteria included not giving a written consent and using medications without an indication which may have an effect on plasma homocysteine and vitamin levels.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thrombosis
Time frame: at least 1 year
1 secondary outcome
High Hcy level
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
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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.
Ahmet Emre Eskazan, MD principal investigator
Istanbul 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 Thrombosis, run by Istanbul University at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 17 Jun 2013. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombosis (time frame: at least 1 year). 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 17 Jun 2013.