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Investigating a Von Willebrand Factor (VWF) Functional Screening Assay for Assigning the Phenotypic Variants of Von Willebrand Disease (VWD) (VWF-phV)

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ClinicalTrials.gov Identifier: NCT02466789
Recruitment Status : Recruiting
First Posted : June 9, 2015
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
Blood Center of Wisconsin
Information provided by (Responsible Party):
Jonathan Roberts, Bleeding and Clotting Disorders Institute Peoria, Illinois

Brief Summary:
The purpose of this study is to improve the investigators ability to diagnose von Willebrand Disease (VWD), a common inherited bleeding disorder. This study will look at a new screening blood test used to determine if a person has VWD. This new screening blood test can determine a diagnosis more rapidly than current blood tests. Also this test could be available at local hospital labs rather than require samples to be sent to bigger more specialized labs.

Condition or disease
Von Willebrands Disease

Detailed Description:
This investigation will be a prospective, multicenter trial to validate the clinical utility of a novel screening assay as a diagnostic screening assay for VWD variants: Type 1C, 2A, 2B, 2M and 2N. Once the subject is enrolled into the study, a minimum of 0.5ml of citrated plasma will be collected and analyzed at the Bleeding and Clotting Disorders Institute Laboratory in Peoria Illinois. Results will be collected: phenotype function profiles will be determined, statistically analyzed and compared to the qualitative data from Blood Center of Wisconsin. Data is expected to correlate as previously shown in prior studies and will confirm the utility of this assay.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Investigating a Von Willebrand Factor (VWF) Functional Screening Assay for Assigning the Phenotypic Variants of Von Willebrand Disease (VWD)
Study Start Date : July 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Validate the novel ELISA-based VWF functional screening assay as a diagnostic screening assay to assign VWD phenotypes 1C, 2A, 2B, 2M and 2N. [ Time Frame: planned analysis at 2 years and 4 years with study duration estimated at 4 years ]

Secondary Outcome Measures :
  1. Further development of the VWF functional screening assay through investigating the incorporation of VWF:CB6 (binding to collagen VI) [ Time Frame: study duration 4 years ]

Biospecimen Retention:   Samples Without DNA
Sodium Citrated Plasma samples


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
New subjects undergoing evaluation for the diagnosis of VWD that are determined to have VWF:ag or VWF:RCo <50 IU/dl and or a VWF:RCo/VWF:ag ratio of <0.7. Also subjects will be included if Type 2N VWD is suspected
Criteria

Inclusion Criteria:

  • New subjects undergoing evaluation for the diagnosis of VWD determined to have a VWF:Ag or VWF: RCo < 50 IU/dl and or a VWF:RCo/VWF:Ag of <0.7. Also subjects will be included if Type 2 N VWD is clinically suspected

Exclusion Criteria:

  • Those subjects whose lab results do not meet the inclusion criteria

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): NCT02466789


Contacts
Contact: Jonathan Roberts, MD 309-692-5337 ext 123 jroberts@ilbcdi.org
Contact: Sarah Gonzales, BS 309-692-5337 ext 135 sgonzales@ilbcdi.org

Locations
United States, Illinois
Bleeding and Clotting Disorders Institute Recruiting
Peoria, Illinois, United States, 61615
Contact: Jonathan Roberts, MD    309-692-5337 ext 123    jroberts@ilbcdi.org   
Contact: Sarah Gonzales, BS    309-692-5337 ext 135    sgonzales@ilbcdi.org   
Principal Investigator: Jonathan Roberts, MD         
Sub-Investigator: Michael D Tarantino, MD         
Sponsors and Collaborators
Jonathan Roberts
Blood Center of Wisconsin
Investigators
Principal Investigator: Jonathan Roberts, MD Bleeding and Clotting Disorders Institute

Publications:

Responsible Party: Jonathan Roberts, Assistant Research Director, Bleeding and Clotting Disorders Institute Peoria, Illinois
ClinicalTrials.gov Identifier: NCT02466789     History of Changes
Other Study ID Numbers: H14-25321
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

Keywords provided by Jonathan Roberts, Bleeding and Clotting Disorders Institute Peoria, Illinois:
Bleeding Disorder, inherited
Von Willebrands Disease
Hematologic Test
VWF
VWD

Additional relevant MeSH terms:
Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn