Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001355
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
1999-11-03
Brief Title:
Detection and Characterization of Host Defense Defects
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Detection and Characterization of Host Defense Defects
Status:
RECRUITING
Status Verified Date:
2024-10-01
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 protocol is designed to evaluate selected patients with documented recurrent or unusual infections and their family members for clinical and laboratory correlates of immune abnormalities It allows long term follow up of patients with host defense defects and permits the periodic study of their blood urine saliva skin stool and vaginal specimens or wound drainage from such patients or their family members for medically indicated purposes and research studies related to understanding the genetic and biochemical bases of these diseases This protocol may help provide patients and materials for the development of therapies for these diseases
This study will
1 Determine the biochemical and genetic causes of inherited immune diseases affecting phagocytes white blood cells that defend against bacterial and fungal infections
2 Try to develop better ways to diagnose and treat patients with these diseases and to prevent diagnose and treat their infections
Patients and family members may undergo the following procedures
A personal and family medical history physical examination and other procedures which may include various blood tests urinalysis saliva collection imaging studies such as chest X-ray computed tomography CT or magnetic resonance imaging MRI and lung function studies dental examination or eye examinations if medically indicated
Patients who have draining wounds will have fluid collected from these wounds for biochemical study
Tissues removed as part of medical care such as pieces of lung liver or teeth or biopsies of these tissues will be studied
Patients who have an immune problem that investigators wish to study further will be asked to return to NIH for follow-up visits at irregular intervals but at least every 6 months The visits will include an updated medical history examination directed at the particular medical problem related to the immune disorder follow-up of abnormal tests or treatment and collection of blood saliva urine or wound fluid for study
Patients may have genetic testing and must be willing to have specimens stored for future research
Family members will have a medical history saliva or urine collection and chest X-ray or other imaging study if medically indicated
Normal volunteers who have had tissue biopsies or pieces of tissue removed as part of medical care such as pieces of lung liver or teeth will have these tissues studied
NIH does not cover the cost of the initial screening visit for travel or lodging A financial assessment may determine if the patient is eligible for financial assistance This study does not enroll children under the age of 2
Patients will be asked to obtain their medical records previous test results or imaging studies prior to the first visit
This study will
1 Determine the biochemical and genetic causes of inherited immune diseases affecting phagocytes white blood cells that defend against bacterial and fungal infections
2 Try to develop better ways to diagnose and treat patients with these diseases and to prevent diagnose and treat their infections
Patients and family members may undergo the following procedures
A personal and family medical history physical examination and other procedures which may include various blood tests urinalysis saliva collection imaging studies such as chest X-ray computed tomography CT or magnetic resonance imaging MRI and lung function studies dental examination or eye examinations if medically indicated
Patients who have draining wounds will have fluid collected from these wounds for biochemical study
Tissues removed as part of medical care such as pieces of lung liver or teeth or biopsies of these tissues will be studied
Patients who have an immune problem that investigators wish to study further will be asked to return to NIH for follow-up visits at irregular intervals but at least every 6 months The visits will include an updated medical history examination directed at the particular medical problem related to the immune disorder follow-up of abnormal tests or treatment and collection of blood saliva urine or wound fluid for study
Patients may have genetic testing and must be willing to have specimens stored for future research
Family members will have a medical history saliva or urine collection and chest X-ray or other imaging study if medically indicated
Normal volunteers who have had tissue biopsies or pieces of tissue removed as part of medical care such as pieces of lung liver or teeth will have these tissues studied
NIH does not cover the cost of the initial screening visit for travel or lodging A financial assessment may determine if the patient is eligible for financial assistance This study does not enroll children under the age of 2
Patients will be asked to obtain their medical records previous test results or imaging studies prior to the first visit
Detailed Description:
This protocol is designed to evaluate selected patients with documented recurrent or unusual infections and their family members for clinical and in vitro correlates of immune abnormalities It will also allow long term follow up of patients with host defense defects and permit us to periodically obtain blood urine saliva skin other excess biopsy tissue breast milk stool and vaginal specimens or wound drainage from such patients or their family members for medically indicated purposes and research studies related to understanding the genetic and biochemical bases of these diseases This protocol may help provide patients and materials for the development of therapies for these diseases in the future
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 |
|---|---|---|---|
| 93-I-0119 | None | None | None |