Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044122
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2002-08-17
Brief Title:
Study of Factors Regulating Mast Cell Proliferation
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Regulation of the Proliferation and Survival of Normal and Neoplastic Human Mast Cells
Status:
RECRUITING
Status Verified Date:
2024-10-16
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 growth factors that promote and inhibit mast cell proliferation resulting in mastocytosis a disease of excessive mast cells in the body These cells can release chemicals that cause itching blisters flushing bone pain and abdominal pain
Patients up to 80 years of age with mastocytosis may be eligible for this 1-day study Participants will have one visit at NIH lasting up to 8 hours during which they will undergo the following tests and procedures
Medical history and physical examination
Laboratory studies if medically indicated
Blood tests to identify genetic changes important in the growth development and functioning of mast cells
Bone marrow aspiration and biopsy
For the bone marrow procedure the skin over the hipbone and the outer surface of the bone itself are numbed with local anesthesia Then a special needle is inserted into the hipbone and about 1 tablespoon of bone marrow is drawn into a syringe Another needle is inserted into the same area to collect a small piece of the bone marrow Additional procedures may include allergen testing urinalysis and 24-hour urine collection
Participants will receive an evaluation of their mastocytosis
Patients up to 80 years of age with mastocytosis may be eligible for this 1-day study Participants will have one visit at NIH lasting up to 8 hours during which they will undergo the following tests and procedures
Medical history and physical examination
Laboratory studies if medically indicated
Blood tests to identify genetic changes important in the growth development and functioning of mast cells
Bone marrow aspiration and biopsy
For the bone marrow procedure the skin over the hipbone and the outer surface of the bone itself are numbed with local anesthesia Then a special needle is inserted into the hipbone and about 1 tablespoon of bone marrow is drawn into a syringe Another needle is inserted into the same area to collect a small piece of the bone marrow Additional procedures may include allergen testing urinalysis and 24-hour urine collection
Participants will receive an evaluation of their mastocytosis
Detailed Description:
This protocol is designed to examine those growth potentiating and inhibiting factors which regulate mast cell number and survival in patients with mastocytosis and to explore the molecular basis of the disease process in hopes of improving therapy Patients will carry the diagnosis of mastocytosis based on abnormal bone marrow biopsy and aspirate abnormal skin biopsy presence of urticaria pigmentosa and if available elevated serum tryptase level 20 ngml and the presence of aberrant mast cell morphology and surface markers of CD2 and CD25 Mastocytosis patients will include children and adults from zero years to 80 years of age Unaffected relatives age 2 to 80 years may also be enrolled The protocol is designated for up to a 1-year enrollment period with only a small number of enrolled patients that will stay on study for more than one visit based on investigator assessment of contribution to study objectives Participants will undergo standard physical exam medical history review and blood collection for clinical and research laboratory evaluations We will collect clinical data and biological specimens for research evaluation from individuals undergoing clinically indicated diagnostic procedures Some patients may participate in research evaluations including buccal swab collection dietary intake assessment stool collection exercise challenge microbiome studies and activity tracking These studies are optional Patients may be asked to re-enter this protocol at a later time for further follow-up
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 |
|---|---|---|---|
| 02-I-0277 | None | None | None |