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Protocol Details

Regulation of the Proliferation and Survival of Normal and Neoplastic Human Mast Cells

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

02-I-0277

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 1 days
Max Age: 80 Years

Referral Letter Required

Yes

Population Exclusion(s)

None

Keywords

Mastocytosis;
Natural History

Recruitment Keyword(s)

Mastocytosis

Condition(s)

Mastocytosis;
Monoclonal;
Bone Marrow;
Tryptase

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

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.

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Eligibility

PATIENT PARTICIPANT INCLUSION CRITERIA:

Participants with mastocytosis zero to 80 years of age may participate in telehealth visits, and two to 80 years of age may participate on-site at NIH Clinical Center.

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 lesions

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

Ability to provide informed consent.

PATIENT PARTICIPANT EXCLUSION CRITERIA:

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

Any condition that in the opinion of the investigator contraindicates participation in this study.

RELATIVE INCLUSION CRITERIA:

Two to 80 years of age.

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

Participant has a primary medical care provider outside the NIH

Ability to provide informed consent.

RELATIVE EXCLUSION CRITERIA:

Any condition that in the opinion of the investigator contraindicates participation in this study.


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Citations:

Carter MC, Metcalfe DD, Komarow HD. Mastocytosis. Immunol Allergy Clin North Am. 2014 Feb;34(1):181-96. doi: 10.1016/j.iac.2013.09.001. Epub 2013 Oct 7.

Chan EC, Bai Y, Kirshenbaum AS, Fischer ER, Simakova O, Bandara G, Scott LM, Wisch LB, Cantave D, Carter MC, Lewis JC, Noel P, Maric I, Gilfillan AM, Metcalfe DD, Wilson TM. Mastocytosis associated with a rare germline KIT K509I mutation displays a well-differentiated mast cell phenotype. J Allergy Clin Immunol. 2014 Jul;134(1):178-87. doi: 10.1016/j.jaci.2013.12.1090. Epub 2014 Feb 28.

Cruse G, Metcalfe DD, Olivera A. Functional deregulation of KIT: link to mast cell proliferative diseases and other neoplasms. Immunol Allergy Clin North Am. 2014 May;34(2):219-37. doi: 10.1016/j.iac.2014.01.002. Epub 2014 Mar 12.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Hirsh D. Komarow, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CLINICAL CENTER BG RM 6D44A
10 CENTER DR
BETHESDA MD 20892
(301) 594-2197
komarowh@mail.nih.gov

Hye Jeong C. Bolan, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 15B1
Room 200
8 West Dr
Bethesda, Maryland 20892
(301) 594-1233
bolanhy@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00044122

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