Investigating a Von Willebrand Factor (VWF) Functional Screening Assay for Assigning the Phenotypic Variants of Von Willebrand Disease (VWD) (VWF-phV)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02466789 |
|
Recruitment Status :
Completed
First Posted : June 9, 2015
Last Update Posted : August 10, 2022
|
Sponsor:
Jonathan Roberts
Collaborator:
Versiti
Information provided by (Responsible Party):
Jonathan Roberts, Bleeding and Clotting Disorders Institute Peoria, Illinois
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |
| Actual Enrollment : | 134 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 |
| Actual Primary Completion Date : | December 31, 2021 |
| Actual Study Completion Date : | June 30, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Von Willebrand disease
Primary Outcome Measures :
- 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 :
- 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
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
Locations
| United States, Illinois | |
| Bleeding and Clotting Disorders Institute | |
| Peoria, Illinois, United States, 61615 | |
Sponsors and Collaborators
Jonathan Roberts
Versiti
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 |
| Other Study ID Numbers: |
H14-25321 |
| First Posted: | June 9, 2015 Key Record Dates |
| Last Update Posted: | August 10, 2022 |
| Last Verified: | August 2022 |
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 |