Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085670
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2004-06-10
Brief Title:
Cytokine Gene Polymorphisms in Bone Marrow Failure
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cytokine Gene Polymorphisms in Bone Marrow Failure
Status:
COMPLETED
Status Verified Date:
2020-09
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:
None
Brief Summary:
This study will examine whether cytokine gene polymorphisms affect the progression or response to therapy of bone marrow failure disorders Cytokine genes instruct cells to produce proteins called cytokines that influence immune system response As with many genes the cytokine genes differ slightly from person to person These differences are called gene polymorphisms Different patients with the same bone marrow failure disease often progress and respond to treatment differently This study will look at the possible role of cytokine gene polymorphisms in these differences
Patients between 2 and 80 years old who have participated in an NHLBI Hematology Branch treatment protocol for acquired aplastic anemia myelodysplastic syndrome or pure red cell aplasia are recruited to participate in this study Blood collected and stored at the time of screening for the treatment protocol will be tested for cytokine gene polymorphisms No additional tests procedures or treatments are involved in this study
Patients between 2 and 80 years old who have participated in an NHLBI Hematology Branch treatment protocol for acquired aplastic anemia myelodysplastic syndrome or pure red cell aplasia are recruited to participate in this study Blood collected and stored at the time of screening for the treatment protocol will be tested for cytokine gene polymorphisms No additional tests procedures or treatments are involved in this study
Detailed Description:
The NHLBI Hematology Branch is investigating features that may affect the clinical course of bone marrow failure patients
We are particularly interested in identifying factors which determine treatment response and outcome Cytokines are biological mediators of the immune response In a normal population there is considerable variation in the precise sequence of the genes which control cytokine production Cytokine Gene Polymorphism or CGP As a consequence individuals differ in the quality of the immune response they mount against self or foreign antigens Since the bone marrow failure disorders aplastic anemia and myelodysplastic syndrome involve auto-immune suppression of marrow function it is important to discover whether there are any recurrent patterns of cytokine production in these disorders which may contribute to the marrow failure This can be done by studying the sequences of the genes that control cytokine production to find out whether there are any recurrent gene patterns in the diseases studied In addition we need to understand why some patients fail to respond to immunosuppressive treatments By comparing CGP in responders and non-responders we may be able to find patterns of cytokine production that are favorable or unfavorable for response Better understanding of CGPs in marrow failure syndromes should make it possible to improve the outcome for patients who fail immune suppression by using drugs which block specific cytokines
None of these polymorphisms are associated with known clinical disease to be classifiable as a genetic defect All testing will be done on samples collected and stored for research purposes from consenting bone marrow failure subjects who have or will be participating on Hematology Branch research protocols
We are particularly interested in identifying factors which determine treatment response and outcome Cytokines are biological mediators of the immune response In a normal population there is considerable variation in the precise sequence of the genes which control cytokine production Cytokine Gene Polymorphism or CGP As a consequence individuals differ in the quality of the immune response they mount against self or foreign antigens Since the bone marrow failure disorders aplastic anemia and myelodysplastic syndrome involve auto-immune suppression of marrow function it is important to discover whether there are any recurrent patterns of cytokine production in these disorders which may contribute to the marrow failure This can be done by studying the sequences of the genes that control cytokine production to find out whether there are any recurrent gene patterns in the diseases studied In addition we need to understand why some patients fail to respond to immunosuppressive treatments By comparing CGP in responders and non-responders we may be able to find patterns of cytokine production that are favorable or unfavorable for response Better understanding of CGPs in marrow failure syndromes should make it possible to improve the outcome for patients who fail immune suppression by using drugs which block specific cytokines
None of these polymorphisms are associated with known clinical disease to be classifiable as a genetic defect All testing will be done on samples collected and stored for research purposes from consenting bone marrow failure subjects who have or will be participating on Hematology Branch research protocols
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-H-0213 | None | None | None |