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Trial record 12 of 456 for:    Inherited Bleeding Disorder

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

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ClinicalTrials.gov Identifier: NCT02096523
Recruitment Status : Enrolling by invitation
First Posted : March 26, 2014
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Ela Shai, Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Inherited Platelet Disorders Other: Blood collection for platelet protein samples Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of Proteomics for the Diagnosis of a Platelet-related Bleeding Disorder
Study Start Date : November 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : February 2023

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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



Primary Outcome Measures :
  1. Levels of detectable platelet proteins [ Time Frame: 2014-2015 (1 year) ]
    Characterize platelet proteome expression profile


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Number of proteins that inducate disease [ Time Frame: 2017-2019 (2 years) ]
    Identify and validate a panel of specific biomarkers candidates



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Ages Eligible for Study:   3 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • History of inherited platelet disorders in the family

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096523


Locations
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Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Ela Shai

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Responsible Party: Ela Shai, Researcher at Hadassah Medical Center, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02096523     History of Changes
Other Study ID Numbers: 002714- HMO-CTIL
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Keywords provided by Ela Shai, Hadassah Medical Organization:
inherited platelet disorders
proteome
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Blood Platelet Disorders
Disease
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders