Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482794
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2007-06-01
Brief Title:
Genetic Risk Factors Associated With Antiphospholipid Antibody Syndrome
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Genetics of Antiphospholipid Antibody Syndrome
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APS
Brief Summary:
Antiphospholipid antibody syndrome APS is characterized by the presence of antiphospholipid antibodies which are proteins in the blood that interfere with the bodys ability to perform normal blood clotting Clinical problems associated with antiphospholipid antibodies include an increased risk for the formation of blood clots in the lungs or deep veins of the legs stroke heart attack and recurrent miscarriages It is possible that some people with APS have a genetic predisposition for developing the syndrome This study will use a genetic strategy to identify potential inherited risk factors for the development of APS by recruiting people with APS who have family members also affected by the syndrome or by another autoimmune disorder such as lupus or rheumatoid arthritis
Detailed Description:
APS is an autoimmune disorder that causes an increased risk for developing a venous or arterial thromboembolism as well as recurrent miscarriages APS frequently occurs in people with lupus and is referred to as secondary APS in this case Many people who have APS however do not have another autoimmune disorder and their disease is referred to as primary APS APS may be a genetic disorder and identifying the genes that predisposes an individual to develop it could lead to a better understanding of the disease as well as improved therapies This study will use a genetic strategy to identify potential risk factors for the development of APS by recruiting people with APS who have family members who are either affected by the syndrome or who have another autoimmune disorder The results of the genetic testing will be compared among the following two groups of families people with APS who also have one or more of their family members affected specifically by APS and people with APS who also have one or more of their family members affected by another type of autoimmune disorder such as lupus or rheumatoid arthritis
Participants in this study will perform a pre-screening questionnaire over the phone to determine relevant clinical diagnoses and collect a brief family history of autoimmune disorders Eligible participants will receive an enrollment package in the mail If possible participants will then report to the study site to supply a detailed family and medical history and provide a blood sample for analysis for antiphospholipid antibodies and preparation of genomic DNA If participants are unable to attend the study visit the interviews will be conducted over the phone Those who are unable to attend the site visit will receive a blood enrollment kit in the mail and these participants will report to a convenient location for phlebotomy services Participants who have already provided blood samples for the APS Collaborative Registry APSCORE may not have to provide another sample for this study Information collected for statistical analysis will include the following data demographic information co-morbid conditions and chronic risk factors lipid profile history of recurrent infections renal failure and cardiovascular disease height and weight details of any medications and supplements currently being taken venous and arterial thromboembolic events and any history of adverse pregnancy outcomes
Participants in this study will perform a pre-screening questionnaire over the phone to determine relevant clinical diagnoses and collect a brief family history of autoimmune disorders Eligible participants will receive an enrollment package in the mail If possible participants will then report to the study site to supply a detailed family and medical history and provide a blood sample for analysis for antiphospholipid antibodies and preparation of genomic DNA If participants are unable to attend the study visit the interviews will be conducted over the phone Those who are unable to attend the site visit will receive a blood enrollment kit in the mail and these participants will report to a convenient location for phlebotomy services Participants who have already provided blood samples for the APS Collaborative Registry APSCORE may not have to provide another sample for this study Information collected for statistical analysis will include the following data demographic information co-morbid conditions and chronic risk factors lipid profile history of recurrent infections renal failure and cardiovascular disease height and weight details of any medications and supplements currently being taken venous and arterial thromboembolic events and any history of adverse pregnancy outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None