Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246857
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2005-10-29
Brief Title:
Screening Protocol for Genetic Diseases of Lymphocyte Homeostasis and Programmed Cell Death
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Screening Protocol for Genetic Diseases of Lymphocyte Homeostasis and Programmed Cell Death
Status:
RECRUITING
Status Verified Date:
2024-10-11
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 determine the biochemical and genetic causes of inherited immune diseases affecting lymphocyte homeostasis Lymphocytes are a type of white blood cell that fights infections Normally the body keeps a precise balance in which lymphocyte growth is matched by lymphocyte death People with constantly enlarged lymph nodes or spleen along with autoimmune disease immunodeficiency lymphoma or other immune problems affecting lymphocytes may have an abnormality of the immune system in the cell growth and cell death processes that regulate lymphocyte homeostasis
Patients who have or are suspected of having an inherited lymphocyte homeostasis or programmed cell death susceptibility syndrome may be eligible for this study Relatives of patients are also included
Participants patients and relatives medical records are reviewed and blood samples are drawn for studies to identify genes involved in immune disorders Tissues that have been removed from patients for medical reasons such as biopsied tissues may be examined for tissue and DNA studies Relatives are studied to determine if some of them may have a very mild form of lymphocyte homeostasis disorder
Patients who have an immune problem that the researchers wish to study further will be invited to donate additional blood samples at irregular intervals at least once a year and to provide an update of their medical records at the same time
Patients who have or are suspected of having an inherited lymphocyte homeostasis or programmed cell death susceptibility syndrome may be eligible for this study Relatives of patients are also included
Participants patients and relatives medical records are reviewed and blood samples are drawn for studies to identify genes involved in immune disorders Tissues that have been removed from patients for medical reasons such as biopsied tissues may be examined for tissue and DNA studies Relatives are studied to determine if some of them may have a very mild form of lymphocyte homeostasis disorder
Patients who have an immune problem that the researchers wish to study further will be invited to donate additional blood samples at irregular intervals at least once a year and to provide an update of their medical records at the same time
Detailed Description:
This protocol is designed to screen patients with suspected or identified genetic diseases of immune cell homeostasis reflecting abnormalities in programmed cell death survival development activation andor proliferation Patients determined by clinical history and initial outside evaluation by their referring physician to be of interest will be consented and enrolled into this study Blood and other biological specimens from patients or their family members will be obtained for research studies related to understanding the genetic and biochemical bases of these diseases Outside medical records will be obtained for chart review to correlate clinical history to research laboratory testing results Results will be relayed to the referring physicians and where applicable patients will be referred to other relevant research studies at the NIH
The study will enroll up to 5000 patients and family members over the next 10 years
The study will enroll up to 5000 patients and family members over the next 10 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 06-I-0015 | None | None | None |