Back to resultsUse of Proteomics for the Diagnosis of a Platelet-related Bleeding Disorder
Primary Purpose
Inherited Platelet Disorders
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Blood collection for platelet protein samples
Sponsored by
About this trial
This is an interventional diagnostic trial for Inherited Platelet Disorders focused on measuring inherited platelet disorders, proteome
Eligibility Criteria
Inclusion Criteria:
- History of inherited platelet disorders in the family
Exclusion Criteria:
- none
Sites / Locations
- Hadassah Medical Organization
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
platelet disease
Healthy
Arm Description
patients with inherited platelet disorders
Healthy family members of patients with inherited platelet disorders
Outcomes
Primary Outcome Measures
Levels of detectable platelet proteins
Characterize platelet proteome expression profile
Secondary Outcome Measures
Changes in protein expression from sick and healthy platelets
Analysis of platelet proteome of sick and healthy members of families with inherited platelet disorders
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02096523
Brief Title
Use of Proteomics for the Diagnosis of a Platelet-related Bleeding Disorder
Official Title
Use of Proteomics for the Diagnosis of a Platelet-related Bleeding Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
July 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ela Shai
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inherited Platelet Disorders
Keywords
inherited platelet disorders, proteome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
platelet disease
Arm Type
Experimental
Arm Description
patients with inherited platelet disorders
Arm Title
Healthy
Arm Type
Experimental
Arm Description
Healthy family members of patients with inherited platelet disorders
Intervention Type
Other
Intervention Name(s)
Blood collection for platelet protein samples
Primary Outcome Measure Information:
Title
Levels of detectable platelet proteins
Description
Characterize platelet proteome expression profile
Time Frame
2014-2015 (1 year)
Secondary Outcome Measure Information:
Title
Changes in protein expression from sick and healthy platelets
Description
Analysis of platelet proteome of sick and healthy members of families with inherited platelet disorders
Time Frame
2015-2019 (4 years)
Other Pre-specified Outcome Measures:
Title
Number of proteins that inducate disease
Description
Identify and validate a panel of specific biomarkers candidates
Time Frame
2017-2019 (2 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
History of inherited platelet disorders in the family
Exclusion Criteria:
none
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Use of Proteomics for the Diagnosis of a Platelet-related Bleeding Disorder
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