Thrombocytopenic PurpuraNCT03244410
Lymphocyte Counts in Immune Thrombocytopenic Purpura
An observational study of Thrombocytopenic Purpura, run by Assiut University.
Trial summary
immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number (cooper N et al 2006) recent studies have demonstrated that the pathogenesis of ITP envolves multifactorial autoimmune mechanisms of both humoral and cellular immunity and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thrombocytopenic Purpura
- What is being tested?
- complete blood picture
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Oct 2017to Jan 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary immune Thrombocytopenic Purpura
Who may be able to join
- Newly diagnosed cases of primary ITP , adults and children.
Who cannot join
- Cases of secondary ITP
About this study
Official title: Initial Lymphocyte Counts Predictive Value in Immune Thrombocytopenic Purpura
- immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number (cooper N et al 2006)
- recent studies have demonstrated that the pathogenesis of ITP envolves multifactorial autoimmune mechanisms of both humoral and cellular immunity and that acute and chronic forms may represent two distinct immunopathological disorders ( cooper N et al 2006) ( Gern Sheimer T 2009 )
Read the detailed description
Immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number ( Cooper N et all 2006) platelet surface membrane proteins become antigenic for unknown reasons, leading to stimulation of the immune system, auto antibodies production and platelet destruction ( Gasbarrini A et all 2000) It is associated with the production of auto antibodies directed against platelet glycoprotein complex 2b/3a and/or 1b/1x , resulting in accelerated destruction of platelets by the reticular endothelial system via the activity of Fcc receptor bearing phagocytic cells ( Provan \& Newland et al 2002) Recent studies have demonstrated that the pathogenesis of ITP envolves multifactorial autoimmune mechanisms of both humoral and cellular immunity and that acute and chronic forms may represent two distinct immunopathological disorders ( Cooper N et al 2006) ( Gern Sheimer T 2009)
There are many phases of the disease:
- Newly diagnosed ITP : for all cases at diagnosis.
- persistent ITP: for patients with ITP between 3 to 12 months.
- chronic ITP: for patients with ITP lasting more than one year ( blood journal 2009).
- Although lymphocytopenia is a commonly reported feature of many chronic autoimmune disorders, differential white cell counts at presentation have seldom been evaluated as predictors for development of chronic ITP ( Deel MD et al 2013) (Ahmed et al 2010)
- Conditions
- Thrombocytopenic Purpura
- Being tested
- complete blood picture
- Medical subject headings
- Purpura, Thrombocytopenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete blood pictureDiagnostic test
complete blood picture
| Study group | Role | What they receive |
|---|---|---|
| immune thrombocytopenic purpura | immune thrombocytopenic purpura an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number we used complete blood picture Receives: Diagnostic Test: complete blood picture |
What is being measured
The primary outcome is the main question the study is designed to answer.
lymphocyte count in immune thrombocytopenic purpura
intital lymphocyte counts predictive value in immune thrombocytopenic purpura by complete blood picture
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study startOct 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dolagy nabil naguib, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244410
- Sponsor's protocol ID
- LCITP
- Status last verified
- Aug 2017
- First submitted
- 7 Aug 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Lymphocyte Counts Predictive Value in Immune Thrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT03244410
- Acronym / sponsor ID
- LCITP
- Conditions
- Thrombocytopenic Purpura
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 9 Aug 2017 (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.
- immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number (cooper N et al 2006)
- recent studies have demonstrated that the pathogenesis of ITP envolves multifactorial autoimmune mechanisms of both humoral and cellular immunity and that acute and chronic forms may represent two distinct immunopathological disorders ( cooper N et al 2006) ( Gern Sheimer T 2009 )
Detailed description
Immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number ( Cooper N et all 2006) platelet surface membrane proteins become antigenic for unknown reasons, leading to stimulation of the immune system, auto antibodies production and platelet destruction ( Gasbarrini A et all 2000) It is associated with the production of auto antibodies directed against platelet glycoprotein complex 2b/3a and/or 1b/1x , resulting in accelerated destruction of platelets by the reticular endothelial system via the activity of Fcc receptor bearing phagocytic cells ( Provan \& Newland et al 2002) Recent studies have demonstrated that the pathogenesis of ITP envolves multifactorial autoimmune mechanisms of both humoral and cellular immunity and that acute and chronic forms may represent two distinct immunopathological disorders ( Cooper N et al 2006) ( Gern Sheimer T 2009)
There are many phases of the disease:
- Newly diagnosed ITP : for all cases at diagnosis.
- persistent ITP: for patients with ITP between 3 to 12 months.
- chronic ITP: for patients with ITP lasting more than one year ( blood journal 2009).
- Although lymphocytopenia is a commonly reported feature of many chronic autoimmune disorders, differential white cell counts at presentation have seldom been evaluated as predictors for development of chronic ITP ( Deel MD et al 2013) (Ahmed et al 2010)
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immune thrombocytopenic purpura | – | Diagnostic Test: complete blood pictureimmune thrombocytopenic purpura an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number we used complete blood picture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary immune Thrombocytopenic Purpura
Key inclusion criteria (1 listed)
- Newly diagnosed cases of primary ITP , adults and children.
Key exclusion criteria (1 listed)
- Cases of secondary ITP
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 |
|---|---|---|
| complete blood picturecomplete blood picture | Diagnostic test | immune thrombocytopenic purpura |
Primary outcome
lymphocyte count in immune thrombocytopenic purpura
Time frame: 15 minutes
intital lymphocyte counts predictive value in immune thrombocytopenic purpura by complete blood picture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenic Purpura, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 9 Aug 2017. 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?
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?
lymphocyte count in immune thrombocytopenic purpura (time frame: 15 minutes). 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 9 Aug 2017.