Inherited Platelet DisordersNCT02096523
Use of Proteomics for the Diagnosis of a Platelet-related Bleeding Disorder
A study testing Blood collection for platelet protein samples in people with Inherited Platelet Disorders, run by Ela Shai at 1 site in Israel.
Trial summary
The goal of this study is to identify the platelet defect responsible for the bleeding in families from our inherited platelet disorders Israeli-Palestinian registry. The investigators plan to characterize platelet proteome expression after removing high abundance proteins. Read more about this study
- Who is it for?
- Ages 3 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Inherited Platelet Disorders
- What is being tested?
- Blood collection for platelet protein samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2016to Jul 2021
- Phase
- Interventional
- 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 3 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- History of inherited platelet disorders in the family
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to identify the platelet defect responsible for the bleeding in families from our inherited platelet disorders Israeli-Palestinian registry. The investigators plan to characterize platelet proteome expression after removing high abundance proteins. The investigators will compare the proteome of sick and healthy members of families with inherited platelet disorders, and identify and validate structural proteins, signaling cascades and biomarkers for detection and diagnosis of unknown platelet disorders. The investigators expect to discover new key findings that allow better understanding of human platelet function and allow better diagnosis and treatment of patients with inherited platelet function disorders.
- Conditions
- Inherited Platelet Disorders
- Being tested
- Blood collection for platelet protein samples
- Keywords
- inherited platelet disorders, proteome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collection for platelet protein samplesOther
| Study group | Role | What they receive |
|---|---|---|
| platelet disease | Experimental | patients with inherited platelet disorders Receives: Other: Blood collection for platelet protein samples |
| Healthy | Experimental | Healthy family members of patients with inherited platelet disorders Receives: Other: Blood collection for platelet protein samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of detectable platelet proteins
Characterize platelet proteome expression profile
Measured: 2014-2015 (1 year)
Secondary outcomes (1)
Changes in protein expression from sick and healthy platelets
Analysis of platelet proteome of sick and healthy members of families with inherited platelet disorders
Measured: 2015-2019 (4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startNov 2016
- Primary completionJan 2021
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inherited Platelet DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ela Shai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ela Shai, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096523
- Sponsor's protocol ID
- 002714- HMO-CTIL
- Status last verified
- Aug 2021
- First submitted
- 20 Mar 2014
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Proteomics for the Diagnosis of a Platelet-related Bleeding Disorder
- ClinicalTrials.gov ID
- NCT02096523
- Acronym / sponsor ID
- 002714- HMO-CTIL
- Conditions
- Inherited Platelet Disorders
- Keywords
- inherited platelet disorders, proteome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ela ShaiUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 26 Mar 2014 (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.
The goal of this study is to identify the platelet defect responsible for the bleeding in families from our inherited platelet disorders Israeli-Palestinian registry. The investigators plan to characterize platelet proteome expression after removing high abundance proteins. The investigators will compare the proteome of sick and healthy members of families with inherited platelet disorders, and identify and validate structural proteins, signaling cascades and biomarkers for detection and diagnosis of unknown platelet disorders. The investigators expect to discover new key findings that allow better understanding of human platelet function and allow better diagnosis and treatment of patients with inherited platelet function disorders.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platelet disease | Experimental | Other: Blood collection for platelet protein samplespatients with inherited platelet disorders |
| Healthy | Experimental | Other: Blood collection for platelet protein samplesHealthy family members of patients with inherited platelet disorders |
Who may qualify
- Ages
- 3 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- History of inherited platelet disorders in the family
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Blood collection for platelet protein samples | Other | Healthy, platelet disease |
Primary outcome
Levels of detectable platelet proteins
Time frame: 2014-2015 (1 year)
Characterize platelet proteome expression profile
1 secondary outcome
Changes in protein expression from sick and healthy platelets
Time frame: 2015-2019 (4 years)
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 25 Aug 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood collection for platelet protein samples in people with Inherited Platelet Disorders, run by Ela Shai at 1 site in Israel.
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 25 Aug 2021. 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 Israel. 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?
Levels of detectable platelet proteins (time frame: 2014-2015 (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 25 Aug 2021.