We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Factors Regulating Mast Cell Proliferation

This study is currently recruiting participants.
Verified September 12, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT00044122
First Posted: August 19, 2002
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
August 17, 2002
August 19, 2002
October 6, 2017
August 16, 2002
Not Provided
Date that the final subject will be examined or an intervention received for the purposes of final collection of data for the primary outcome [ Time Frame: 08/18/2027 ]
Not Provided
Complete list of historical versions of study NCT00044122 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Factors Regulating Mast Cell Proliferation
Regulation of the Proliferation and Survival of Normal and Neoplastic Human Mast Cells

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.

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 ng/ml and the presence of aberrant mast cell morphology and surface markers of CD2 and CD25. Medical work-up is in accordance with standard medical practice. Mastocytosis patients will be children and adults from two years to 80 years of age. 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. Patients may be asked to re-enter this protocol at a later time for further research or entry into protocol 98-I-0027. This is not a therapeutic protocol. Treatment using FDA licensed/approved drugs may be provided to patients on a case-by-case basis at the discretion of the principal investigator. and This protocol does not involve infusion of any manipulated cells, viruses or DNA constructs into human subjects.
Observational
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Mastocytosis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
550
Not Provided
Not Provided
  • PARTICIPANT INCLUSION CRITERIA:

Birth to 80 years of age.

Histologic evidence of increased mast cell number by bone marrow and/or skin biopsy or documentation of mastocytosis in the skin

supported with a photograph of diagnostic skin lesion

Must be under the care of a primary care physician to be enrolled.

Patients must be able and willing to undergo a bone marrow biopsy. A bone marrow biopsy will be pre-empted if, during the procedure, the patient experiences significant flushing, pain, hypotension or tachycardia for any reason, which places the patient at risk. A patient may decline to have a bone marrow biopsy if the bone marrow sample is only for research purposes.

Bone marrow biopsy will be performed on children only if medically indicated. Research samples will be collected at that time only if the procedure does not increase the risks to the child.

PARTICIPATIENT EXCLUSION CRITERIA:

No primary care physician.

Anemia with hemoglobin less than 8 g/dL, hematocrit less than 24.

RELATIVE INCLUSION CRITERIA:

A biological relative with or without the diagnosis of mastocytosis by skin examination or histologic evidence in a skin or bone marrow biopsy

Subject has a primary medical care provider outside the NIH

RELATIVE EXCLUSION CRITERIA:

No primary care physician.

Anemia with hemoglobin < 8 g/dL, hematocrit < 24.

Sexes Eligible for Study: All
2 Years to 80 Years   (Child, Adult, Senior)
No
Contact: Robin R. Eisch, R.N. (301) 443-1720 eischar@mail.nih.gov
Contact: Dean D Metcalfe, M.D. (301) 761-6780 dmetcalfe@niaid.nih.gov
United States
 
 
NCT00044122
020277
02-I-0277
Not Provided
Not Provided
Not Provided
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Dean D Metcalfe, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
September 12, 2017