Use of Proteomics for the Diagnosis of a Platelet-related Bleeding Disorder

August 24, 2021 updated by: Ela Shai
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of inherited platelet disorders in the family

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: platelet disease
patients with inherited platelet disorders
Other: Blood collection for platelet protein samples
Experimental: Healthy
Healthy family members of patients with inherited platelet disorders
Other: Blood collection for platelet protein samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of detectable platelet proteins
Time Frame: 2014-2015 (1 year)
Characterize platelet proteome expression profile
2014-2015 (1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in protein expression from sick and healthy platelets
Time Frame: 2015-2019 (4 years)
Analysis of platelet proteome of sick and healthy members of families with inherited platelet disorders
2015-2019 (4 years)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of proteins that inducate disease
Time Frame: 2017-2019 (2 years)
Identify and validate a panel of specific biomarkers candidates
2017-2019 (2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ela Shai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

March 20, 2014

First Submitted That Met QC Criteria

March 23, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002714- HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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